Identity
- Trade Name
- Batrik PrAmLi Power Lube FDA UDI
- Generic Name
- Medical device disinfection agent FDA UDI
- Device Name
- PrAmLi Power3 Lube, Instrument Lubricant, Concentrate, 3.8 L FDA UDI
- Model / Reference
- SS-21-6001 FDA UDI
- Description
- PrAmLi Power3 Lube, Instrument Lubricant, Concentrate, 3.8 L FDA UDI
Identifiers
- Catalog Number
- SS-21-6001 FDA UDI
- Primary DI / UDI-DI
- 00690521016736 FDA UDI
- FDA Product Code
- MNL FDA UDI
- GMDN Term
- Medical device disinfection agent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.1500 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
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
No
FDA UDI
Category: Medical device disinfection agent
Batrik PrAmLi Power Lube by Batrik Medical Manufacturing Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medical device disinfection agent.
- Patterson® — PATTERSON DENTAL SUPPLY, INC. · Class I
- Instru Zym — Laboratorium Dr. Deppe GmbH · Class I
- Your First Enzymatic & Non-Enzymatic Sponges — BATRIK MEDICAL MANUFACTURING INC. · Class I
- Rapidzyme PR — Novapharm Research (Australia) Pty Ltd · Class IIb
- Olie Medical Performance Enzymatic 5 — Amity Limited · Class I
- Coltene Biosonic UC40 — Topdental (Products) Ltd · Class I
- Enzymatic Detergent — QUADRALENE LTD · Class I
- Enzym Med Wipes — Laboratorium Dr. Deppe GmbH · 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
- Batrik Medical Manufacturing Inc
Sources (1)
- FDA UDI 85c2a119-cff8-43a5-8d4e-3c3192d3e2bd 36 fields · synced May 30, 2026