FDA UDI
In Commercial Distribution
🇺🇸 United States
GORE SEAMGUARD Bioabsorbable Staple Line Reinforce
DI: 00733132655519
·
Model: CBSG31
·
W. L. Gore & Associates, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- GORE SEAMGUARD Bioabsorbable Staple Line Reinforce
- Primary DI
- 00733132655519
- Version / Model
- CBSG31
- Catalog Number
- CBSG31
- 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
- 2022-12-05
- Public Version
- 2
- Public Version Date
- 2023-08-14
- Public Version Status
- Update
- Public Device Record Key
- 5a58c52f-445b-4a45-8c09-eb8d9740a954
Device Description
US SURGICAL 31
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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| 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), 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 |
|---|---|---|---|---|---|---|
| Primary | 00733132655519 | GS1 | ||||
| Package | 00733132600779 | GS1 | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)528-8763
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K053200 | 000 |