Therapak

FDA UDI

Class I (US FDA UDI)

by Therapak LLC

Identity

Trade Name: Therapak FDA UDI
Generic Name: Urine strainer FDA UDI
Device Name: StoneScreen Collection and Transport Kit (CS/16) FDA UDI
Model / Reference: ACSK38879 FDA UDI
Description: StoneScreen Collection and Transport Kit (CS/16) FDA UDI

Identifiers

Catalog Number: ACSK38879 FDA UDI
Primary DI / UDI-DI: 07312058462741 FDA UDI
FDA Product Code: NNK FDA UDI
GMDN Term: Urine strainer FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 864.3250 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Urine strainer

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 fc8aa76b-67ba-44df-81fe-7dcccbeedc24 34 fields · synced Jun 8, 2026