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Zimmer Biomet Timberline Lateral Fusion System Wave Guide
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 8735-0042Model Spine Lateral Fusion System Wave Guide 3.5mm Max Cable Diameter
Identity
- Trade Name
- Zimmer Biomet Timberline Lateral Fusion System Wave Guide FDA UDI
- Generic Name
- Open surgical site internal light FDA UDI
- Model / Reference
- 8735-0042 EUDAMEDFDA UDISpine Lateral Fusion System Wave Guide 3.5mm Max Cable Diameter EUDAMED
Identifiers
- Catalog Number
- 011998 FDA UDI
- Primary DI / UDI-DI
- 00812432022907 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00812432022907 EUDAMED
- FDA Product Code
- FDG FDA UDI
- EMDN Code
- V9012 NON-SPECIALIST SURGICAL INSTRUMENTS AND KITS, SINGLE-USE EUDAMED
- GMDN Term
- Open surgical site internal light FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 876.4530 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Category: Open surgical site internal light
Zimmer Biomet Timberline Lateral Fusion System Wave Guide by Lumitex, Inc. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Lumitex, Inc.
Sources (2)
- FDA UDI 53c1a12e-bedc-4216-abb8-5ac78e13cf45 33 fields · synced Jun 19, 2026
- EUDAMED 5699d135-40aa-4add-9d30-ce3f47046c55 61 fields · synced Jun 19, 2026