Identity
- Trade Name
- NOVOSTITCH FDA UDI
- Generic Name
- Suturing unit, single-use FDA UDI
- Device Name
- NOVOSTITCH PRO MENISCAL RPR SYS 0 FDA UDI
- Model / Reference
- CTX-A004 FDA UDI
- Description
- NOVOSTITCH PRO MENISCAL RPR SYS 0 FDA UDI
Identifiers
- Catalog Number
- CTX-A004 FDA UDI
- Primary DI / UDI-DI
- 00853541006051 FDA UDI
- FDA Product Code
- GAT FDA UDI
- GMDN Term
- Suturing unit, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5000 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Suturing unit, single-use
Novostitch by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Suturing unit, single-use.
- eXact 5.1 — Cypris Medical · Class I
- Arthrex® — Arthrex, Inc. · Class I
- 25° Left, Champion®+ Slider with Nitinol Passing Wire — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION · Class I
- Arthrex® — Arthrex, Inc. · Class I
- OverStitch NXT Endoscopic Suturing System — Apollo Endosurgery · Class II
- SlingShot — Stryker Corp. · Class I
- NanoPass — Stryker Corp. · Class I
- DISPOSABLE NITINOL NDL SINGLE PACK — Biomet Orthopedics, Inc. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI a074c35c-cf5a-4a1d-86d1-db740a2e2097 36 fields · synced Jun 8, 2026