HEPRO.US Standard Surgical Gown 68 gsm

FDA UDI

Class II (US FDA UDI)

by Hepro.us Inc.

Identity

Trade Name: HEPRO.US Standard Surgical Gown 68 gsm FDA UDI
Generic Name: Surgical gown, single-use FDA UDI
Device Name: Standard Surgical Gown 68 gsm Single Pouch FDA UDI
Model / Reference: Single Pouch Standard Surgical Gown 68gsm FDA UDI
Description: Standard Surgical Gown 68 gsm Single Pouch FDA UDI

Identifiers

Primary DI / UDI-DI: 00854427007964 FDA UDI
FDA Product Code: KKX FDA UDI
GMDN Term: Surgical gown, single-use 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 gown, single-use

HEPRO.US Standard Surgical Gown 68 gsm by Hepro.us Inc. — 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: Hepro.us Inc.

Sources (1)

FDA UDI 2847fcbb-58fd-4037-b6e6-27f85578ea96 33 fields · synced Jun 6, 2026