FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Biofiber™
DI: 00846832006052
·
Model: BBF0008DU
·
TORNIER, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Biofiber™
- Primary DI
- 00846832006052
- Version / Model
- BBF0008DU
- Catalog Number
- BBF0008DU
- Company Name
- TORNIER, INC.
- Labeler DUNS
- 968990812
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-16
- Public Version
- 8
- Public Version Date
- 2025-08-18
- Public Version Status
- Update
- Public Device Record Key
- df258209-cef6-4f0c-aae8-eb0ff3c1a545
- Distribution End Date
- 2022-06-30
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
- Yes
- 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 |
|---|---|---|---|---|
| FTL | Mesh, surgical, polymeric | General, Plastic Surgery | 878.3300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44688 | Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable | An implantable material (e.g., flat sheet) made from a bioabsorbable synthetic polymer(s) [e.g., polyglycolic acid (PGA), polyglycolide] intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. It may also be intended as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation may be supplied with the mesh. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10846832006059 | GS1 | 4 | Not in Commercial Distribution | 2022-06-30 | |
| Primary | 00846832006052 | GS1 |
Customer Contacts
- Phone
- +1(888)494-7950
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 8 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- High: 45 Degrees Celsius