Saljet

FDA UDI

Class U (US FDA UDI)

by Winchester Laboratories, Lllp

Identity

Trade Name: Saljet FDA UDI
Generic Name: Wound irrigation sterile saline FDA UDI
Device Name: Saljet 40 is a single use disposable polymer vial with a twist off top containing 30ml of sterile normal saline 0.9% w/v. It contains no preservatives, surfactants or buffering. The vials are packed into an outer shelf carton. Forty vials per carton. FDA UDI
Model / Reference: Saljet 40 FDA UDI
Description: Saljet 40 is a single use disposable polymer vial with a twist off top containing 30ml of sterile normal saline 0.9% w/v. It contains no preservatives, surfactants or buffering. The vials are packed into an outer shelf carton. Forty vials per carton. FDA UDI

Identifiers

Primary DI / UDI-DI: 10188151000005 FDA UDI
510(k) Number: K993969 FDA UDI
FDA Product Code: FRO FDA UDI
GMDN Term: Wound irrigation sterile saline FDA UDI

Classification

Device Class: U FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

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

Saljet by Winchester Laboratories, Lllp — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K993969 also covers:

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: Winchester Laboratories, Lllp

Sources (1)

FDA UDI b84a811d-f4be-4ec1-bada-957045c01495 34 fields · synced Jun 8, 2026