Identity
- Trade Name
- HCS FDA UDI
- Generic Name
- General-body orifice lubricant FDA UDI
- Device Name
- Lubricating Jelly, 5g Foil Pack, Sterile FDA UDI
- Model / Reference
- HCS0212 FDA UDI
- Description
- Lubricating Jelly, 5g Foil Pack, Sterile FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810132040641 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General-body orifice lubricant
Hcs by Concordance Healthcare Solutions LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General-body orifice lubricant.
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- PRO ADVANTAGE — NATIONAL DISTRIBUTION & CONTRACTING, INC. · Class I
- Sterile Bacteriostatic Lubricating Gel — Micro-tech Usa · Class I
- DynaLube, Sterile, 2.7 g Packet — Dynarex Corp. · Class I
- Medline — MEDLINE INDUSTRIES, INC. · 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
- Concordance Healthcare Solutions LLC
Sources (1)
- FDA UDI 9bafa1d8-684d-404a-b2e5-17a604bcca49 33 fields · synced May 31, 2026