FDA UDI
In Commercial Distribution
🇺🇸 United States
MINT
DI: 08809779586102
·
Model: MINT-I 17WC1710A
·
Hans Biomed Corp.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MINT
- Primary DI
- 08809779586102
- Version / Model
- MINT-I 17WC1710A
- Company Name
- Hans Biomed Corp.
- Labeler DUNS
- 689512625
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-03-08
- Public Version
- 1
- Public Version Date
- 2022-03-16
- Public Version Status
- New
- Public Device Record Key
- b4c4a150-ed96-4952-aa2a-ae87f662e68a
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- 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 |
|---|---|---|---|---|
| NEW | Suture, Surgical, Absorbable, Polydioxanone | General, Plastic Surgery | 878.4840 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46859 | Lift thread, bioabsorbable | A sterile filament made of a bioabsorbable material [e.g., poly-L-lactide (PLLA), poly(lactic-co-glycolic acid) (PLGA)] with projections (e.g., barbs or cones) along its length intended to be surgically implanted typically during a cosmetic surgical procedure for alternative lifting (e.g., face, neck, breast). The device is inserted through dermis and tacked to deep fascia where the projections produce tension for elevation of the subdermis. It is available in a variety of lengths and may be supplied with dedicated disposable implantation tools (e.g., needle, cannula). | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08809779586102 | GS1 |