Identity
- Trade Name
- Sterile Bacteriostatic Lubricating Gel FDA UDI
- Generic Name
- General-body orifice lubricant FDA UDI
- Device Name
- Sterile Bacteriostatic Lubricating Gel FDA UDI
- Model / Reference
- MDJL1A0001A FDA UDI
- Description
- Sterile Bacteriostatic Lubricating Gel FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858276007557 FDA UDI
- FDA Product Code
- KMJ FDA UDI
- GMDN Term
- General-body orifice lubricant FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6375 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
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
Yes
FDA UDI
Category: General-body orifice lubricant
Sterile Bacteriostatic Lubricating Gel by Micro-tech Usa — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-body orifice lubricant.
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- Medline — MEDLINE INDUSTRIES, INC. · Class I
- NAR Kit — NORTH AMERICAN RESCUE, LLC. · 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
- Micro-tech Usa
Sources (1)
- FDA UDI 883ead02-de23-4942-a742-d8d871e64c94 33 fields · synced Jun 8, 2026