Identity
- Trade Name
- Medline FDA UDI
- Generic Name
- Single-administration urethral catheterization kit, single-use FDA UDI
- Device Name
- 18FR10ML TMP100%SIL UM 1LYR C FDA UDI
- Model / Reference
- UROT1037 FDA UDI
- Description
- 18FR10ML TMP100%SIL UM 1LYR C FDA UDI
Identifiers
- Catalog Number
- UROT1037 FDA UDI
- Primary DI / UDI-DI
- 10889942652853 FDA UDI
- FDA Product Code
- OHR 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
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Single-administration urethral catheterization kit, single-use
Medline by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Medline Industries, Inc.
Sources (1)
- FDA UDI cc4af019-2155-45bf-b950-7cc5df39638f 35 fields · synced Jun 6, 2026