Core Values

FDA UDI

Class U (US FDA UDI)

by Harmon Stores, Inc.

Identity

Trade Name: Core Values FDA UDI
Generic Name: Wound irrigation sterile saline FDA UDI
Device Name: Saline Wound Wash FDA UDI
Model / Reference: 8709 FDA UDI
Description: Saline Wound Wash FDA UDI

Identifiers

Primary DI / UDI-DI: 00034197008709 FDA UDI
FDA Product Code: FRO FDA UDI
FQH FDA UDI
GMDN Term: Wound irrigation sterile saline FDA UDI

Classification

Device Class: U FDA UDI
Regulation Number: 880.5475 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Wound irrigation sterile saline

Core Values by Harmon Stores, Inc. — Class U — 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 U	Pending data

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Manufacturer

Manufacturer: Harmon Stores, Inc.

Sources (1)

FDA UDI 8ccd7699-2d95-4775-a634-b9537cec9b34 35 fields · synced May 30, 2026