FDA UDI
In Commercial Distribution
🇺🇸 United States
GORE BIO-A Tissue Reinforcement
DI: 00733132605422
·
Model: FS0915
·
W. L. Gore & Associates, Inc.
Product Codes
4
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- GORE BIO-A Tissue Reinforcement
- Primary DI
- 00733132605422
- Version / Model
- FS0915
- Catalog Number
- FS0915
- Company Name
- W. L. Gore & Associates, Inc.
- Labeler DUNS
- 967358115
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-13
- Public Version
- 11
- Public Version Date
- 2023-12-22
- Public Version Status
- Update
- Public Device Record Key
- 72c54021-20ec-4587-b75d-cde4b289a371
Device Description
BIO-A TISSUE REINFORCEMENT 9cmX15cm
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
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| OXC | Mesh, surgical, absorbable, staple line reinforcement | General, Plastic Surgery | 878.3300 | 2 |
| OWZ | Mesh, surgical, absorbable, thoracic, chest wall reconstruction | General, Plastic Surgery | 878.3300 | 2 |
| OWT | Mesh, surgical, absorbable, abdominal hernia | General, Plastic Surgery | 878.3300 | 2 |
| OXF | Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery | 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), polycarbonate (PC), polyglycolide or carbon fibres] 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 |
|---|---|---|---|---|---|---|
| Secondary | H373FS091533 | HIBCC | ||||
| Primary | 00733132605422 | GS1 |
Customer Contacts
- Phone
- +1(800)528-8763
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 9 | Centimeter | |
| Length | 15 | Centimeter |