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Vitale

FDA UDI

Class U (US FDA UDI)

by CellEra, LLC

Identity

Trade Name
Vitale FDA UDI
Generic Name
Pressure-regulated wound irrigation solution applicator, manual FDA UDI
Device Name
Wound Wash Jet System each bottle (2fl oz, 60ml), 12 bottles/box, 4 boxes/case FDA UDI
Model / Reference
25160 FDA UDI
Description
Wound Wash Jet System each bottle (2fl oz, 60ml), 12 bottles/box, 4 boxes/case FDA UDI

Identifiers

Catalog Number
25160 FDA UDI
Primary DI / UDI-DI
00856276008468 FDA UDI
FDA Product Code
FRO FDA UDI
FQH FDA UDI
GMDN Term
Pressure-regulated wound irrigation solution applicator, manual 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

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

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

Vitale by CellEra, LLC — Class U — 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
CellEra, LLC

Sources (1)

  • FDA UDI 686d1c17-3cba-44c4-b1a9-208d7711d2d3 35 fields · synced May 31, 2026