Identity
- Trade Name
- MTG FDA UDI
- Generic Name
- Single-administration urethral catheterization kit, single-use FDA UDI
- Device Name
- EZ-Advancer 14FR with PVP FDA UDI
- Model / Reference
- 31114 FDA UDI
- Description
- EZ-Advancer 14FR with PVP FDA UDI
Identifiers
- Catalog Number
- 31114 FDA UDI
- Primary DI / UDI-DI
- 00850025153270 FDA UDI
- 510(k) Number
- K080878 FDA UDI
- FDA Product Code
- KOD FDA UDI
- GMDN Term
- Single-administration urethral catheterization kit, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5130 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
Yes
FDA UDI
Convenience Kit
Yes
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: Single-administration urethral catheterization kit, single-use
Mtg by H R Pharmaceuticals, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Single-administration urethral catheterization kit, single-use.
- OneCath — COMPACTCATH, INC · Class II
- MTG EZ-Advancer® Mini-Pak — Medical Technologies of Georgia · Class II
- SureCath — Coloplast A/S · Class II
- LoFric® Hydro-Kit™ — Wellspect AB · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- COMPACTCATH — COMPACTCATH, INC · Class II
- VaPro Plus Pocket Kit — Hollister Incorporated · Class II
- MTG EZ-Gripper® Long — Medical Technologies of Georgia · Class II
Cleared under the same submission
K080878 also covers:
- MTG — H R Pharmaceuticals, Inc.
- MTG — H R Pharmaceuticals, Inc.
- MTG — H R Pharmaceuticals, Inc.
- MTG — H R Pharmaceuticals, Inc.
- MTG — H R Pharmaceuticals, Inc.
- MTG — H R Pharmaceuticals, Inc.
- MTG — H R Pharmaceuticals, Inc.
- MTG — H R Pharmaceuticals, Inc.
- MTG — H R Pharmaceuticals, Inc.
- MTG — H R Pharmaceuticals, Inc.
- MTG Cath-Lean® — Medical Technologies of Georgia
- MTG Cath-Lean® — Medical Technologies of Georgia
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 II | Pending data |
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Manufacturer
- Manufacturer
- H R Pharmaceuticals, Inc.
Sources (1)
- FDA UDI ce38a1b8-5424-4d79-80b3-22c100d7113d 36 fields · synced Jun 8, 2026