FDA UDI
In Commercial Distribution
🇺🇸 United States
BioBrace
DI: 10653405990147
·
Model: BB40X60
·
Conmed Corporation
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- BioBrace
- Primary DI
- 10653405990147
- Version / Model
- BB40X60
- Catalog Number
- BB40X60
- Company Name
- Conmed Corporation
- Labeler DUNS
- 071595540
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-20
- Public Version
- 2
- Public Version Date
- 2026-03-16
- Public Version Status
- Update
- Public Device Record Key
- 2c739c86-7a90-497b-a757-52ea25811ac5
Device Description
BioBrace® Reinforced Implant, 40 x 60 mm
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
- 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 |
|---|---|---|---|---|
| OWW | Mesh, surgical, absorbable, orthopaedics, reinforcement of tendon | General, Plastic Surgery | 878.3300 | 2 |
| OWY | Mesh, surgical, collagen, orthopaedics, reinforcement of tendon | General, Plastic Surgery | 878.3300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60907 | Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial | A bioabsorbable, implantable material (e.g., flat sheet) made from animal-derived collagen intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]; some types may also be intended for use as a short-term scaffold for tissue regeneration. It is constructed of collagen, which might be cross-linked (e.g., with glutaraldehyde); it does not include antimicrobial agents/materials. 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 | 20653405990144 | GS1 | Pouch | 1 | In Commercial Distribution | |
| Primary | 10653405990147 | GS1 |
Customer Contacts
- Phone
- +1(866)426-6633
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K241906 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 60 | Millimeter | |
| Width | 40 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius