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Procellera Single Layer

FDA UDI

Class U (US FDA UDI)

by Vomaris Wound Care, Inc.

Identity

Trade Name
Procellera Single Layer FDA UDI
Generic Name
Bioelectric wound dressing FDA UDI
Device Name
Procellera Single Layer Rx, 5" x 5" FDA UDI
Model / Reference
5" x 5" FDA UDI
Description
Procellera Single Layer Rx, 5" x 5" FDA UDI

Identifiers

Catalog Number
VSR-0505 FDA UDI
Primary DI / UDI-DI
00810198030808 FDA UDI
510(k) Number
K160783 FDA UDI
FDA Product Code
FRO FDA UDI
GMDN Term
Bioelectric wound dressing 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

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: Bioelectric wound dressing

Procellera Single Layer by Vomaris Wound Care, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bioelectric wound dressing.

Cleared under the same submission

K160783 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Vomaris Wound Care, Inc.

Sources (1)

  • FDA UDI 138b51c4-95b3-4ad2-90f4-448b2087cc49 36 fields · synced May 30, 2026