FDA UDI
In Commercial Distribution
🇺🇸 United States
NeuroFlex
DI: 00813954020112
·
Model: CNCF6025
·
COLLAGEN MATRIX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NeuroFlex
- Primary DI
- 00813954020112
- Version / Model
- CNCF6025
- Company Name
- COLLAGEN MATRIX, INC.
- Labeler DUNS
- 176262442
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-16
- Public Version
- 4
- Public Version Date
- 2021-12-08
- Public Version Status
- Update
- Public Device Record Key
- 9ff5bfa0-1c1a-4534-9bae-78a1aa8d0ef6
Device Description
Flexible Collagen Nerve Cuff 6mm (inner diameter) x 2.5cm (length)
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 |
|---|---|---|---|---|
| JXI | Cuff, Nerve | Neurology | 882.5275 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43233 | Nerve guide, bioabsorbable, animal-derived | An implantable tubular device intended to be used to create a tunnel through which a discontinuous peripheral nerve can regenerate to bridge the proximal and distal nerve stumps. The device is typically used during hand surgery and/or nerve reconstruction. It is made of an animal-derived material (e.g., porcine-derived collagen matrix, chitosan) that can be chemically degraded and typically absorbed via natural body processes. It is also known as a nerve sheath, nerve cuff, nerve protector, nerve conduit, or a nerve wrap. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00813954020112 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K131541 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 2.5 | Centimeter | |
| Lumen/Inner Diameter | 6 | Millimeter |