Identity
- Trade Name
- TIPCONTROL FDA UDI
- Generic Name
- Orthopaedic bur, single-use FDA UDI
- Device Name
- NUCLEUS RESECTOR ARTICULATING Ø 5.5MM for soft tissue extraction, in endoscopic spine surgery, for use with motor handpieces M5/0 and M5/3, WL 350mm, PU= 3 pcs, sterile, for single use FDA UDI
- Model / Reference
- 499751005 FDA UDI
- Description
- NUCLEUS RESECTOR ARTICULATING Ø 5.5MM for soft tissue extraction, in endoscopic spine surgery, for use with motor handpieces M5/0 and M5/3, WL 350mm, PU= 3 pcs, sterile, for single use FDA UDI
Identifiers
- Catalog Number
- 499751005 FDA UDI
- Primary DI / UDI-DI
- 04055207053805 FDA UDI
- FDA Product Code
- HWE FDA UDI
- GMDN Term
- Orthopaedic bur, 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
No
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
Dimensions & Sizes
- Size
- Outer Diameter — 5.5 Millimeter FDA UDI
Category: Orthopaedic bur, single-use
Tipcontrol by Richard Wolf GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Richard Wolf GmbH
Sources (1)
- FDA UDI e5198c53-eb39-4764-bf8c-b0725593f86c 37 fields · synced Jun 6, 2026