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Busse Hospital Disposables

FDA UDI

Class II (US FDA UDI)

by Robert Busse & Co., Inc.

Identity

Trade Name
Busse Hospital Disposables FDA UDI
Generic Name
Patient surgical drape, single-use FDA UDI
Device Name
Ophathalmic Drape w/ 2 1/2" Fenestration & Adhesive Patch, 15" x 15" FDA UDI
Model / Reference
685 FDA UDI
Description
Ophathalmic Drape w/ 2 1/2" Fenestration & Adhesive Patch, 15" x 15" FDA UDI

Identifiers

Catalog Number
685 FDA UDI
Primary DI / UDI-DI
00849233013407 FDA UDI
FDA Product Code
KKX FDA UDI
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

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Patient surgical drape, single-use

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

Similar devices

Also classified as Patient surgical drape, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Robert Busse & Co., Inc.

Sources (1)

  • FDA UDI 74d09387-d3ba-4e36-a7eb-c27d5087d693 35 fields · synced May 30, 2026