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Shur-Clens

FDA UDI

Class II (US FDA UDI)

by Asept Pak, Inc.

Identity

Trade Name
Shur-Clens FDA UDI
Generic Name
Pressure-regulated wound irrigation solution applicator, manual FDA UDI
Device Name
Inner Carton containing 20 containers of 20 mL each of Hypochlorous Acid Solution FDA UDI
Model / Reference
980099 FDA UDI
Description
Inner Carton containing 20 containers of 20 mL each of Hypochlorous Acid Solution FDA UDI

Identifiers

Primary DI / UDI-DI
10850073677008 FDA UDI
FDA Product Code
FQH FDA UDI
GMDN Term
Pressure-regulated wound irrigation solution applicator, manual FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5475 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

Yes

FDA UDI

Over-the-Counter

Yes

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: Pressure-regulated wound irrigation solution applicator, manual

Shur-Clens by Asept Pak, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pressure-regulated wound irrigation solution applicator, manual.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Asept Pak, Inc.

Sources (1)

  • FDA UDI e363f30c-c29a-46d5-b691-3e0df5c893ac 35 fields · synced Jun 8, 2026