← Back to catalogue

Busse Hospital Disposables

FDA UDI

Class I (US FDA UDI)

by Robert Busse & Co., Inc.

Identity

Trade Name
Busse Hospital Disposables FDA UDI
Generic Name
Visitor hygiene coverall FDA UDI
Device Name
Coveralls - Extra Large, white, zipper front FDA UDI
Model / Reference
213 FDA UDI
Description
Coveralls - Extra Large, white, zipper front FDA UDI

Identifiers

Primary DI / UDI-DI
10849233003825 FDA UDI
FDA Product Code
LYU FDA UDI
GMDN Term
Visitor hygiene 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Visitor hygiene coverall

Busse Hospital Disposables by Robert Busse & Co., Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Visitor hygiene coverall.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Robert Busse & Co., Inc.

Sources (1)

  • FDA UDI b7026d2b-1225-48b6-ad88-c82239597470 34 fields · synced May 30, 2026