Identity
- Trade Name
- One Care Set FDA UDI
- Generic Name
- Surgical instrument maintenance lubricant FDA UDI
- Device Name
- Care Set FDA UDI
- Model / Reference
- 08064970 FDA UDI
- Description
- Care Set FDA UDI
Identifiers
- Primary DI / UDI-DI
- J021080649701 FDA UDI
- FDA Product Code
- EFB FDA UDI
- GMDN Term
- Surgical instrument maintenance lubricant FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Category: Surgical instrument maintenance lubricant
One Care Set by W & H Dentalwerk Bürmoos GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical instrument maintenance lubricant.
- Sklar® — Sklar Corporation · Class I
- ContraClean — Stryker Corp. · Class I
- CURVTEK LUBRICANT, 1OZ — Biomet Orthopedics, Inc. · Class I
- Sky-Lube — Skytron, LLC · Class II
- Primado2 — NAKANISHI INC. · Class I
- Surgical Milk — Germiphene Corp. · Class I
- PREMIXSLIP (4.2oz/125ml with mister) — Ruhof Corporation · Class I
- Lubricare Maintenance System — Bien-Air Dental SA · 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
- W & H Dentalwerk Bürmoos GmbH
Sources (1)
- FDA UDI cc1a1fea-3c00-4177-8a22-9d609d24c5c5 33 fields · synced Jun 8, 2026