PlastCare

FDA UDI

Class II (US FDA UDI)

by Proguard Health Inc.

Identity

Trade Name: PlastCare FDA UDI
Generic Name: Sterilization packaging, single-use FDA UDI
Device Name: Sterilization Pouches (4.25" x 12") FDA UDI
Model / Reference: PG-4312 FDA UDI
Description: Sterilization Pouches (4.25" x 12") FDA UDI

Identifiers

Catalog Number: PG-4312 FDA UDI
Primary DI / UDI-DI: D066PG43121 FDA UDI
FDA Product Code: JOJ FDA UDI
FRG FDA UDI
GMDN Term: Sterilization packaging, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.2800 FDA UDI
880.6850 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

MRI Safety

MR Safe FDA UDI

Category: Sterilization packaging, single-use

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

Similar devices

Also classified as Sterilization packaging, single-use.

Dental City — ICP, INC. · Class II
Essentials by 3D Dental — 3D DENTAL DESIGNS AND DEVELOPMENT, LLC · Class II
CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
VIVIT Supply — Vivit Supply LLC · Class II
Medline — MEDLINE INDUSTRIES, INC. · Class II
Arjo Wiggins Medical, Inc. — Sterimed, Inc. · Class II
Patterson® — PATTERSON DENTAL SUPPLY, INC. · Class II
Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C. · Class II

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 II	Pending data

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

Manufacturer

Manufacturer: Proguard Health Inc.

Sources (1)

FDA UDI 0cb9fff3-ceea-4f5f-badd-f2df767b3840 34 fields · synced May 30, 2026