Asp Medical

FDA UDI

Class I (US FDA UDI)

by Asp Global, LLC

Identity

Trade Name: ASP MEDICAL FDA UDI
Generic Name: Surgical coverall FDA UDI
Device Name: COVERALL, BLUE, 3XLARGE, OPEN CUFF, OPEN ANKLE, TRADITIONAL COLLAR, ZIPPER FRONT, SBPP, 5EA/BG, 10BG/CS FDA UDI
Model / Reference: GNT210-CV1 FDA UDI
Description: COVERALL, BLUE, 3XLARGE, OPEN CUFF, OPEN ANKLE, TRADITIONAL COLLAR, ZIPPER FRONT, SBPP, 5EA/BG, 10BG/CS FDA UDI

Identifiers

Primary DI / UDI-DI: 00840216108691 FDA UDI
FDA Product Code: LYU FDA UDI
GMDN Term: Surgical coverall FDA UDI

Classification

Device Class: Class I 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

Yes

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

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Surgical coverall

Asp Medical by Asp Global, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical coverall.

Dukal — Dukal LLC · Class I
Curaplex — BOUND TREE MEDICAL, LLC · Class I
Dukal — Dukal LLC · Class I
Dukal — Dukal LLC · Class I
INDALJIMTM — Indaljim, S.A. de C.V. · Class I
TSW — Xiantao TSW Protective Products Co., Ltd · Class I
VARIOSONIC — BENCO DENTAL SUPPLY CO. · Class I
VARIOSONIC — BENCO DENTAL SUPPLY CO. · 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 I	Pending data

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

Manufacturer

Manufacturer: Asp Global, LLC

Sources (1)

FDA UDI 8cc4c169-4da6-4201-ab6c-5735319e7264 33 fields · synced May 30, 2026