Identity
- Trade Name
- HANDPIECE LUBE OIL FDA UDI
- Generic Name
- Surgical instrument maintenance lubricant FDA UDI
- Model / Reference
- 10-7538 FDA UDI
Identifiers
- Primary DI / UDI-DI
- D9281075380 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Surgical instrument maintenance lubricant FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical instrument maintenance lubricant
Handpiece Lube Oil by W.H. Holden, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical instrument maintenance lubricant.
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- Surgical Milk — Germiphene Corp. · Class I
- PREMIXSLIP (4.2oz/125ml with mister) — Ruhof Corporation · 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 |
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Manufacturer
- Manufacturer
- W.H. Holden, Inc.
Sources (1)
- FDA UDI e9fbe6f6-6785-4f9f-9780-6a09a7c9b14c 32 fields · synced Jun 8, 2026