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: Umbilical cord clamp, single-use FDA UDI
Device Name: Umbilical Cord Clamp, Bulk FDA UDI
Model / Reference: 385 FDA UDI
Description: Umbilical Cord Clamp, Bulk FDA UDI

Identifiers

Catalog Number: 385 FDA UDI
Primary DI / UDI-DI: 00849233018105 FDA UDI
510(k) Number: K010835 FDA UDI
FDA Product Code: HFW FDA UDI
GMDN Term: Umbilical cord clamp, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.4530 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: Umbilical cord clamp, 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 Umbilical cord clamp, single-use.

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Argyle — Cardinal Health 200, LLC · Class I
DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
Double-Grip Umbilical Cord Clamp — Aspen Surgical Products, Inc. · Class II
DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
Centurion — Centurion Medical Products · Class II
Centurion — Centurion Medical Products · Class II
Argyle — Cardinalhealth · Class I

Cleared under the same submission

K010835 also covers:

Busse Hospital Disposables — ROBERT BUSSE & CO., INC.

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: Robert Busse & Co., Inc.

Sources (1)

FDA UDI 976ff449-e9de-4887-bc97-f06bac929448 36 fields · synced Jun 1, 2026