PlastCare

FDA UDI

Class I (US FDA UDI)

by Proguard Health Inc.

Identity

Trade Name: PlastCare FDA UDI
Generic Name: Dental chair, electric FDA UDI
Device Name: Headrest Covers Sleeves (10" x 14") FDA UDI
Model / Reference: PG-STR-S1014 FDA UDI
Description: Headrest Covers Sleeves (10" x 14") FDA UDI

Identifiers

Catalog Number: PG-STR-S1014 FDA UDI
Primary DI / UDI-DI: D066PGSTRS10141 FDA UDI
FDA Product Code: FRK FDA UDI
GMDN Term: Dental chair, electric FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 880.6140 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Dental chair, electric

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

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MTI — MEDICAL TECHNOLOGY INDUSTRIES, INC. · Class I
Forest — Ls Enterprises, Inc. · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Proguard Health Inc.

Sources (1)

FDA UDI f1a7cc82-359e-432b-bf81-43f8d5fbf49b 34 fields · synced Jun 8, 2026