FDA UDI
In Commercial Distribution
🇺🇸 United States
RESTYLANE DEFYNE
DI: 08437027710063
·
Model: Gel 1 mL Syringe
·
SAIMA GLOBAL FARMA S.L.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- RESTYLANE DEFYNE
- Primary DI
- 08437027710063
- Version / Model
- Gel 1 mL Syringe
- Company Name
- SAIMA GLOBAL FARMA S.L.
- Labeler DUNS
- 468910220
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-30
- Public Version
- 1
- Public Version Date
- 2025-07-08
- Public Version Status
- New
- Public Device Record Key
- 552eaa0b-dfc2-4f14-9f40-6326a0eee5c2
Device Description
RESTYLANE DEFYNE is a sterile, biodegradable, transparent gel of non-animal cross-linked hyaluronic acid with the addition of lidocaine hydrochloride 0.3%. It is is indicated in patients over the age of 21 for injection into the mid-to-deep dermis for correction of moderate to severe, deep facial wrinkles and folds (such as nasolabial folds) and for augmentation of the chin region to improve the chin profile in patients with mild to moderate chin retrusion.
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 |
|---|---|---|---|---|
| 47887 | Dermal tissue reconstructive material, microbe-derived, anaesthetic | 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 includes a local anaesthetic agent (e.g., lidocaine). 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 | 08437027710063 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P140029 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 25 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- – 77 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not expose to direct sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Refrigeration not required
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not freeze