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SoftBiopsy

FDA UDI

Class I (US FDA UDI)

by Histologics Llc

Identity

Trade Name
SoftBiopsy FDA UDI
Generic Name
Cervical cytology brush FDA UDI
Device Name
Gynecological biopsy device for tissue collection, storage, and transport. FDA UDI
Model / Reference
SFT-1000 FDA UDI
Description
Gynecological biopsy device for tissue collection, storage, and transport. FDA UDI

Identifiers

Catalog Number
SFT-1000 FDA UDI
Primary DI / UDI-DI
00860275000316 FDA UDI
FDA Product Code
HFB FDA UDI
GEE FDA UDI
GMDN Term
Cervical cytology brush FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
884.4530 FDA UDI
878.4800 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: Cervical cytology brush

SoftBiopsy by Histologics Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cervical cytology brush.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Histologics Llc

Sources (1)

  • FDA UDI b81e7db9-14be-451e-84ee-ffa9bcdc9cf6 35 fields · synced May 30, 2026