← Back to catalogue
MTG Soft Intermittent Catheter /Coude W/Indicator Line
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- MTG Soft Intermittent Catheter /Coude W/Indicator Line FDA UDI
- Generic Name
- Single-administration urethral catheterization kit, single-use FDA UDI
- Device Name
- Intermittent Catheter Coude-tip with hydrophilic low-friction coating and indicator line FDA UDI
- Model / Reference
- 81712 FDA UDI
- Description
- Intermittent Catheter Coude-tip with hydrophilic low-friction coating and indicator line FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851593006487 FDA UDI
- 510(k) Number
- K111405 FDA UDI
- FDA Product Code
- GBM 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 12 French FDA UDI
Category: Single-administration urethral catheterization kit, single-use
MTG Soft Intermittent Catheter /Coude W/Indicator Line by Medical Technologies of Georgia — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Single-administration urethral catheterization kit, single-use.
- OneCath — COMPACTCATH, INC · 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
- OneCath Hydro — COMPACTCATH, INC · Class II
- LoFric® Origo™ — Wellspect AB · Class II
Cleared under the same submission
K111405 also covers:
- TruCath — H R Pharmaceuticals, Inc.
- TruCath — H R Pharmaceuticals, Inc.
- TruCath — H R Pharmaceuticals, Inc.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medical Technologies of Georgia
Sources (1)
- FDA UDI 1961785e-25a5-476c-99e4-e3da1132418c 37 fields · synced May 30, 2026