← Back to catalogue

Procellera Composite

FDA UDI

Class U (US FDA UDI)

by Vomaris Wound Care, Inc.

Identity

Trade Name
Procellera Composite FDA UDI
Generic Name
Bioelectric wound dressing FDA UDI
Device Name
Procellera Composite OTC; 4"x4" FDA UDI
Model / Reference
4"x4" FDA UDI
Description
Procellera Composite OTC; 4"x4" FDA UDI

Identifiers

Catalog Number
VHC-0404 FDA UDI
Primary DI / UDI-DI
00810198030402 FDA UDI
510(k) Number
K180533 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 Composite 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

K180533 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Vomaris Wound Care, Inc.

Sources (1)

  • FDA UDI e0ab9b2f-4464-47d3-a950-da95adc1f938 36 fields · synced May 30, 2026