Identity
- Trade Name
- Zuma-L FDA UDI
- Generic Name
- Bone awl, reusable FDA UDI
- Device Name
- Zuma-L Awl FDA UDI
- Model / Reference
- 95-6005 FDA UDI
- Description
- Zuma-L Awl FDA UDI
Identifiers
- Catalog Number
- 95-6005 FDA UDI
- Primary DI / UDI-DI
- 10889981097615 FDA UDI
- FDA Product Code
- HWJ FDA UDI
- GMDN Term
- Bone awl, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bone awl, reusable
Zuma-L by SeaSpine Orthopedics Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone awl, reusable.
- Vital™ MIS Spinal Fixation System — BIOMET SPINE LLC · Class I
- Trigen — Smith & Nephew, Inc. · Class I
- Navigated Instruments — EVOLUTION SPINE, LLC · Class II
- PYRENEES Cervical Plate System — K2M, INC. · Class I
- Awl — SIGNATURE ORTHOPAEDICS PTY LTD · Class I
- CONMED — Conmed Corporation · Class I
- Sklar® — Sklar Corporation · Class I
- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, 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
- SeaSpine Orthopedics Corporation
Sources (1)
- FDA UDI e2b6ad28-37e0-4d75-90cf-c3961dccf0b5 35 fields · synced Jun 8, 2026