Identity
- Trade Name
- Soft-ECC-S FDA UDI
- Generic Name
- Endocervical specimen collection kit FDA UDI
- Device Name
- Endocervical curette system (small size) for tissue collection, storage, and transport. FDA UDI
- Model / Reference
- SFT-2100 FDA UDI
- Description
- Endocervical curette system (small size) for tissue collection, storage, and transport. FDA UDI
Identifiers
- Catalog Number
- SFT-2100 FDA UDI
- Primary DI / UDI-DI
- 00860275000330 FDA UDI
- FDA Product Code
- HCY FDA UDI
- GMDN Term
- Endocervical specimen collection kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 884.4530 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
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endocervical specimen collection kit
Soft-ECC-S by Histologics Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endocervical specimen collection kit.
- Soft-ECC — HISTOLOGICS LLC · 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
- Histologics Llc
Sources (1)
- FDA UDI 7dab76c1-aef9-412c-9c0f-53036017f614 35 fields · synced May 30, 2026