Alleset

FDA UDI

Class II (US FDA UDI)

by GRI Medical & Electronic Technology Co., Ltd.

Identity

Trade Name: Alleset FDA UDI
Generic Name: Patient surgical drape, single-use FDA UDI
Device Name: Impervious Interventional Femoral Angiography Drape_W/ windows_W/side panel_87x75in_S_20ea/cs FDA UDI
Model / Reference: 80-01108A1-S FDA UDI
Description: Impervious Interventional Femoral Angiography Drape_W/ windows_W/side panel_87x75in_S_20ea/cs FDA UDI

Identifiers

Primary DI / UDI-DI: 16931918128030 FDA UDI
FDA Product Code: PUI FDA UDI
GMDN Term: Patient surgical drape, 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

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Patient surgical drape, single-use

Alleset by GRI Medical & Electronic Technology Co., Ltd. — 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: GRI Medical & Electronic Technology Co., Ltd.

Sources (1)

FDA UDI 27b583c3-a56e-4a9a-90b3-ed257536e401 34 fields · synced Sep 18, 2026