Identity
- Trade Name
- Halsted Health FDA UDI
- Generic Name
- Urinary incontinence penis sheath/port, single-use FDA UDI
- Device Name
- Silicone Male External Catheter. Self-Adhering. Non-Sterile. FDA UDI
- Model / Reference
- Size 29MM - # 7729-30 FDA UDI
- Description
- Silicone Male External Catheter. Self-Adhering. Non-Sterile. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860006105037 FDA UDI
- FDA Product Code
- NNX FDA UDI
- GMDN Term
- Urinary incontinence penis sheath/port, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.5250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Urinary incontinence penis sheath/port, single-use
Halsted Health by Flex Source International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urinary incontinence penis sheath/port, single-use.
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- UltraFlex™ Self-Adhering Male External Catheter — C. R. Bard, Inc. · Class I
- LHB Industries — The Lighthouse For the Blind, Inc. · Class I
- SureStep Male External Catheter System Green Replacement Kit — C. R. Bard, Inc. · Class I
- Clear Advantage Male Continence Sheath — C. R. Bard, Inc. · Class I
- Wideband Male External Catheter — C. R. Bard, Inc. · Class I
- LHB Industries — The Lighthouse For the Blind, 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
- Flex Source International, Inc.
Sources (1)
- FDA UDI 50c63d7b-e6c1-4317-b894-abdf797778ff 34 fields · synced Jun 8, 2026