Therapak

FDA UDI

Class I (US FDA UDI)

by Therapak LLC

Identity

Trade Name: Therapak FDA UDI
Generic Name: General specimen collection kit FDA UDI
Device Name: 14 Vial Prostate Biopsy Transport Kit (CS/20) FDA UDI
Model / Reference: ACSK38870 FDA UDI
Description: 14 Vial Prostate Biopsy Transport Kit (CS/20) FDA UDI

Identifiers

Catalog Number: ACSK38870 FDA UDI
Primary DI / UDI-DI: 00810185250424 FDA UDI
FDA Product Code: FCH FDA UDI
GMDN Term: General specimen collection kit FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 876.4730 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: General specimen collection kit

Therapak by Therapak LLC — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Therapak LLC

Sources (1)

FDA UDI cc9974dd-9e43-4d14-a668-6cd5d7853aba 34 fields · synced May 30, 2026