SEDY FILL 80CC: Clinical Specifications & Data Sheet
Medically Reviewed Protocol | Target: Board-Certified Dermatologists & Plastic Surgeons | ISO 13485 Compliant Manufacturing
SEDY FILL 80CC is a high-volume, monophasic, cross-linked hyaluronic acid (HA) dermal filler engineered for macro-volumization. Manufactured via bio-fermentation, it utilizes a proprietary HENM (High Efficiency Network Macromolecule) cross-linking technology to maximize the viscoelastic profile required for deep tissue body contouring.
Quantitative Composition & Physical Properties
Chemical Composition
HA Concentration: 20 mg/mL
Source: Streptococcus zooepidemicus (Non-animal)
Cross-linking Agent: BDDE
Residual BDDE: < 2 ppm
Endotoxin Level: < 0.25 EU/mL
pH Level: 6.8 – 7.5
Rheological Data
Structure: Monophasic, homogenous gel
Elastic Modulus (G’): Optimized for high tissue projection
Viscous Modulus (G”): Adjusted for cannula flow
Particle Size: Macroporous optimization for body
Degradation Profile: Isovolumetric
Packaging & Storage
Volume: 80 cc (80 mL) per vial
Format: Sterile glass vial
Sterilization: Autoclave sterilization (Steam)
Shelf Life: 24 months from manufacturing
Storage Protocol: 1°C – 30°C. Do not freeze. Protect from direct sunlight.
Clinical Application Protocol
This device mandates administration exclusively by licensed medical practitioners trained in advanced subcutaneous and supraperiosteal injection techniques. Strict adherence to aseptic protocols is required.
Indications
- Restoration of structural volume in the gluteal region.
- Correction of morphological asymmetries.
- Volumetric augmentation of atrophic body regions.
- Post-liposuction contour alignment.
Injection Parameters
- Target Plane: Deep subcutaneous fat layer / Supra-muscular layer.
- Delivery System: 16G – 18G blunt-tip cannula recommended for large volume; 27G needle for localized correction.
- Technique: Retrograde linear threading, fanning, or micro-bolus techniques.
- Longevity: 12 to 24 months (Metabolism-dependent).
Strict Contraindications & Medical Disclaimer
SEDY FILL 80CC is an Rx-only medical device. Administration by unauthorized personnel poses severe health risks.
Contraindications: Do not administer to patients with documented hypersensitivity to hyaluronic acid, Gram-positive bacterial proteins, or lidocaine. Absolute contraindications include localized active skin inflammation/infection, autoimmune disorders, uncontrolled systemic diseases, coagulation defects, and pregnancy or lactation. Do not inject into the intravascular space, intramuscular tissue, or highly vascularized facial areas. Extravascular injection must be confirmed prior to extrusion to prevent vascular occlusion.
Post-Procedural Management: Prohibit intense physical exertion, exposure to extreme thermal changes (sauna, cryotherapy), and excessive mechanical pressure on the augmented area for a minimum of 14 days post-administration. Immediate medical intervention is mandatory upon signs of ischemia, severe edema, or prolonged erythema.

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