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MTG Pediatric Intermittent Catheter, Straight-tip with hydrophilic low-friction
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- MTG Pediatric Intermittent Catheter, Straight-tip with hydrophilic low-friction FDA UDI
- Generic Name
- Single-administration urethral catheterization kit, single-use FDA UDI
- Device Name
- Pediatric Intermittent Catheter, Straight-tip with hydrophilic coating FDA UDI
- Model / Reference
- 81108 FDA UDI
- Description
- Pediatric Intermittent Catheter, Straight-tip with hydrophilic coating FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851593006166 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 — 8 French FDA UDI
Category: Single-administration urethral catheterization kit, single-use
MTG Pediatric Intermittent Catheter, Straight-tip with hydrophilic low-friction by Medical Technologies of Georgia — Class II — FDA UDI — listed in FDA GUDID
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Also classified as Single-administration urethral catheterization kit, single-use.
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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 |
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Manufacturer
- Manufacturer
- Medical Technologies of Georgia
Sources (1)
- FDA UDI 64f4e43d-87fd-450e-9523-e90e1b534ba9 37 fields · synced Jun 8, 2026