Identity
- Trade Name
- DeRoyal FDA UDI
- Generic Name
- Indwelling urethral catheterization kit, adult FDA UDI
- Device Name
- OPEN HEART FOLEY KIT PGYBK FDA UDI
- Model / Reference
- 89-8655 FDA UDI
- Description
- OPEN HEART FOLEY KIT PGYBK FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00749756869607 FDA UDI
- FDA Product Code
- FCM FDA UDI
- GMDN Term
- Indwelling urethral catheterization kit, adult 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
No
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: Indwelling urethral catheterization kit, adult
A comprehensive overview of the DeRoyal Indwelling Urethral Catheterization Kit, including its features, compliance, and user guidance. This medical device is designed for adult or pediatric patients undergoing urinary drainage from the bladder.
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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
- Deroyal Industries, Inc.
Sources (1)
- FDA UDI 90d3a00a-9960-45d9-a20d-a7ec7b2de208 34 fields · synced Oct 7, 2026