Identity
- Trade Name
- nexis® FDA UDI
- Generic Name
- Cannulated surgical drill bit, single-use FDA UDI
- Device Name
- Single Use Instrumentation FDA UDI
- Model / Reference
- SUI01001 FDA UDI
- Description
- Single Use Instrumentation FDA UDI
Identifiers
- Catalog Number
- SUI01001 FDA UDI
- Primary DI / UDI-DI
- 03700879507866 FDA UDI
- FDA Product Code
- HWE FDA UDI
- GMDN Term
- Cannulated surgical drill bit, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cannulated surgical drill bit, single-use
nexis® by Novastep — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cannulated surgical drill bit, single-use.
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class I
- Sierra™ — SeaSpine Orthopedics Corporation · Class II
- VersiTomic Low Profile Ø11.0 mm — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION · Class I
- FOREFOOT SOLUTIONS™ — Newdeal Sas · Class I
- APEX 3D S Total Ankle Replacement System — Paragon 28 · Class I
- Arthrex® — Arthrex, Inc. · Class I
- Arthrex® — Arthrex, Inc. · Class I
- MEDLINE — MEDLINE INDUSTRIES, 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Novastep
Sources (1)
- FDA UDI 43a735e0-ecc8-4871-976b-0a36376cf4ff 35 fields · synced Jun 7, 2026