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PlastCare

FDA UDI

Class I (US FDA UDI)

by Proguard Health Inc.

Identity

Trade Name
PlastCare FDA UDI
Generic Name
Implantable-device infection control barrier FDA UDI
Device Name
Barrier Film Black FDA UDI
Model / Reference
PG-BAR-BLK FDA UDI
Description
Barrier Film Black FDA UDI

Identifiers

Catalog Number
PG-BAR-BLK FDA UDI
Primary DI / UDI-DI
D066PGBARBLK1 FDA UDI
FDA Product Code
IWX FDA UDI
GMDN Term
Implantable-device infection control barrier FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
892.6500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Implantable-device infection control barrier

PlastCare by Proguard Health Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Implantable-device infection control barrier.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Proguard Health Inc.

Sources (1)

  • FDA UDI b4951593-fdad-4987-8364-85ef591a2253 34 fields · synced May 30, 2026