Identity
- Trade Name
- KOLPLAST FDA UDI
- Generic Name
- General specimen collection kit FDA UDI
- Model / Reference
- ESCOVA PP/ESPATULA PLAST 25UN FDA UDI
Identifiers
- Catalog Number
- TPCAP25 FDA UDI
- Primary DI / UDI-DI
- 07898027908460 FDA UDI
- 510(k) Number
- K153128 FDA UDI
- FDA Product Code
- HHT FDA UDI
- GMDN Term
- General specimen collection kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4530 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
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
Yes
FDA UDI
Category: General specimen collection kit
Kolplast by Kolplast CI SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K153128 also covers:
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
- Kolplast CI SA
Sources (1)
- FDA UDI c9a21a66-99ca-435b-ba3b-cbd6ca881a1c 34 fields · synced May 30, 2026