FDA UDI
In Commercial Distribution
🇺🇸 United States
Neurotube
DI: 00844735006186
·
Model: GEM0240NT
·
SYNOVIS MICRO COMPANIES ALLIANCE, INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Neurotube
- Primary DI
- 00844735006186
- Version / Model
- GEM0240NT
- Catalog Number
- 531101240011
- Company Name
- SYNOVIS MICRO COMPANIES ALLIANCE, INC
- Labeler DUNS
- 031284586
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-04-23
- Public Version
- 3
- Public Version Date
- 2024-08-20
- Public Version Status
- Update
- Public Device Record Key
- dcec7274-2d51-48f2-af50-a139b2b3ed6b
Device Description
The NEUROTUBE device Absorbable Woven Polyglycolic Acid Mesh Tube is designed for primary or secondary peripheral nerve repair or reconstruction.
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
- 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 |
|---|---|---|---|---|
| JXI | CUFF, NERVE | Neurology | 882.5275 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44814 | Nerve guide, synthetic polymer, bioabsorbable | An implantable device intended to be used 1) to create a tunnel through which a discontinuous peripheral nerve can regenerate to bridge the proximal and distal nerve ends, 2) to encase a nerve for protection to aid in repair [e.g., to prevent ingrowth of scar tissue], or 3) for capping the end of an amputated nerve to prevent the formation of a neuroma. It is made of bioabsorbable synthetic polymer(s) in the form of a solid tube or a gel which polymerises in situ, and is designed to be chemically degraded and absorbed via natural body processes. It is also known as a nerve sheath, nerve cuff, nerve protector, nerve conduit, nerve wrap, or nerve cap. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00844735006186 | GS1 |
Customer Contacts
- Phone
- +1(800)933-0303
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K983007 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 40 | Millimeter | |
| Lumen/Inner Diameter | 2.3 | Millimeter |