PlastCare

FDA UDI

Class I (US FDA UDI)

by Proguard Health Inc.

Identity

Trade Name: PlastCare FDA UDI
Generic Name: Syringe dispensing gun, reusable FDA UDI
Device Name: Silicone Dispenser Gun 4:1 & 10:1 FDA UDI
Model / Reference: PG-G4100 FDA UDI
Description: Silicone Dispenser Gun 4:1 & 10:1 FDA UDI

Identifiers

Catalog Number: PG-G4100 FDA UDI
Primary DI / UDI-DI: D066PGG41001 FDA UDI
FDA Product Code: DZN FDA UDI
GMDN Term: Syringe dispensing gun, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4565 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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: Syringe dispensing gun, reusable

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

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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 6c5f370a-835e-424e-88ec-827ae7296569 34 fields · synced May 30, 2026