HEPRO. US General Pack - 10 Pouches-Case

FDA UDI

Class II (US FDA UDI)

by Hepro.us Inc.

Identity

Trade Name: HEPRO. US General Pack - 10 Pouches-Case FDA UDI
Generic Name: Surgical/examination garment kit FDA UDI
Device Name: 1PC Mayo Stand, 2Pc OP-Tape, 2Pc Hand Towel,2Pc Side Drape, 1Pc Top Drape, 1Pc Foot Drape, 2 Pc Reinforced table Cover, 1Pc Wrapper 10 Pouches per Case FDA UDI
Model / Reference: CT - General Pack FDA UDI
Description: 1PC Mayo Stand, 2Pc OP-Tape, 2Pc Hand Towel,2Pc Side Drape, 1Pc Top Drape, 1Pc Foot Drape, 2 Pc Reinforced table Cover, 1Pc Wrapper 10 Pouches per Case FDA UDI

Identifiers

Primary DI / UDI-DI: 00854427007124 FDA UDI
FDA Product Code: ERY FDA UDI
GMDN Term: Surgical/examination garment kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4370 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Surgical/examination garment kit

HEPRO. US General Pack - 10 Pouches-Case by Hepro.us Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical/examination garment kit.

Lab Coats Knitted Cuffs & Collar with Pockets, 2X-Large, White — Dynarex Corp. · Class I
GRYPHON BRANDS — Gryphon Brands Inc. · Class I
GRYPHON BRANDS — Gryphon Brands Inc. · Class I
ASP MEDICAL — Asp Global, LLC · Class I
Medline — MEDLINE INDUSTRIES, INC. · Class II
Centurion — Centurion Medical Products · Class II
VR — POLYCONVERSIONS, INC. · Class I
VR — POLYCONVERSIONS, 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 II	Pending data

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

Manufacturer

Manufacturer: Hepro.us Inc.

Sources (1)

FDA UDI a2c12a4d-85e7-471e-a650-e8755555043f 33 fields · synced May 30, 2026