FDA UDI
In Commercial Distribution
🇺🇸 United States
NeuraGen® 3D
DI: 10381780266754
·
Model: PNGM520
·
Integra Lifesciences Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NeuraGen® 3D
- Primary DI
- 10381780266754
- Version / Model
- PNGM520
- Catalog Number
- PNGM520
- Company Name
- Integra Lifesciences Corporation
- Labeler DUNS
- 083171244
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-15
- Public Version
- 2
- Public Version Date
- 2024-02-22
- Public Version Status
- Update
- Public Device Record Key
- 9b463efc-2876-47d4-a591-629094229dd2
Device Description
NeuraGen Advanced Nerve Guide Matrix 5mm x 2cm
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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 |
|---|---|---|---|---|
| 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 | 10381780266754 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K163457 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 5 | Millimeter | |
| Length | 2 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius