ProCure

FDA UDI

Class II (US FDA UDI)

by Twin Med, LLC

Identity

Trade Name: ProCure FDA UDI
Generic Name: Surgical/examination garment kit FDA UDI
Device Name: Earloop Face Masks 3-Ply ASTM Level 1 - 50ea/bx 20bx/cs FDA UDI
Model / Reference: PC622B FDA UDI
Description: Earloop Face Masks 3-Ply ASTM Level 1 - 50ea/bx 20bx/cs FDA UDI

Identifiers

Catalog Number: PC622B FDA UDI
Primary DI / UDI-DI: 10840330703434 FDA UDI
FDA Product Code: FXX FDA UDI
GMDN Term: Surgical/examination garment kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4040 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

Yes

FDA UDI

Dimensions & Sizes

Size: Length — 6.9 Inch FDA UDI
Height — 3.75 Inch FDA UDI

Category: Surgical/examination garment kit

ProCure by Twin Med, LLC — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Twin Med, LLC

Sources (1)

FDA UDI c8f8f8f6-f085-4e82-9c22-b7fd808ac60d 36 fields · synced May 30, 2026