FDA UDI
In Commercial Distribution
🇺🇸 United States
Restylane Silk
DI: 00302995967352
·
Model: Gel 1.0 ml syringe - demo
·
Q-Med AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Restylane Silk
- Primary DI
- 00302995967352
- Version / Model
- Gel 1.0 ml syringe - demo
- Company Name
- Q-Med AB
- Labeler DUNS
- 355371873
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-08
- Public Version
- 1
- Public Version Date
- 2023-06-16
- Public Version Status
- New
- Public Device Record Key
- 12e52aba-8d28-49b4-989d-089390b3b867
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LMH | Implant, Dermal, For Aesthetic Use | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59131 | Dermal tissue reconstructive material, microbe-derived | A sterile, bioabsorbable, bacteria-derived substance intended to be injected into the dermis/hypodermis of the skin, lip submucosa, and/or for supraperiosteal administration to add volume by serving as a space-occupying supplement to the intercellular matrix of connective tissue (dermal filler), typically to correct cutaneous contour deformities (e.g., wrinkles, folds, scars) associated with aging, injury, or degenerative lesions; it does not include a local anaesthetic agent. It typically includes bacterial hyaluronic acid (HA) as the principal constituent and is typically preloaded in a disposable syringe; disposable needle(s)/cannula(e) dedicated to injection may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00302995967352 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P040024 | 072 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Refrigeration not required
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not freeze
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not expose to direct sunlight
- Type
- Storage Environment Temperature
- Temperature Range
- – 77 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- – 25 Degrees Celsius