Identity
- Trade Name
- TruCath FDA UDI
- Generic Name
- Urine-sampling urethral catheter FDA UDI
- Device Name
- Male Hydro Coude 16FR SOFT FDA UDI
- Model / Reference
- HC1616S FDA UDI
- Description
- Male Hydro Coude 16FR SOFT FDA UDI
Identifiers
- Catalog Number
- HC1616S FDA UDI
- Primary DI / UDI-DI
- 00850025153317 FDA UDI
- 510(k) Number
- K111405 FDA UDI
- FDA Product Code
- GBM FDA UDI
- GMDN Term
- Urine-sampling urethral catheter 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
Yes
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
Category: Urine-sampling urethral catheter
TruCath by H R Pharmaceuticals, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urine-sampling urethral catheter.
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- MALE PLAIN INTERMITTENT CATHETER STRAIGHT TIP 14CH — FLEXICARE MEDICAL LIMITED · Class II
- MALE PLAIN INTERMITTENT CATHETER COUDE TIP 16CH — FLEXICARE MEDICAL LIMITED · Class II
- MALE PLAIN INTERMITTENT CATHETER COUDE TIP 12CH — FLEXICARE MEDICAL LIMITED · Class II
- PAEDIATRIC PLAIN INTERMITTENT CATHETER STRAIGHT TIP 10CH — FLEXICARE MEDICAL LIMITED · Class II
- MALE PLAIN INTERMITTENT CATHETER COUDE TIP 8CH — FLEXICARE MEDICAL LIMITED · Class II
Cleared under the same submission
K111405 also covers:
- 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.
- 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
- H R Pharmaceuticals, Inc.
Sources (1)
- FDA UDI 6b8efef8-ee02-4f63-816a-64cdddcedf06 36 fields · synced Jun 1, 2026