Brasseler USA

FDA UDI

Class I (US FDA UDI)

by Peter Brasseler Holdings, LLC

Identity

Trade Name: Brasseler USA FDA UDI
Generic Name: Scalpel handle, reusable FDA UDI
Device Name: MH6SS MIRROR HDL SS #6 HDL 1P FDA UDI
Model / Reference: 5023625U0 FDA UDI
Description: MH6SS MIRROR HDL SS #6 HDL 1P FDA UDI

Identifiers

Primary DI / UDI-DI: 00887919684114 FDA UDI
FDA Product Code: EJB FDA UDI
GMDN Term: Scalpel handle, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4565 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Scalpel handle, reusable

Brasseler USA by Peter Brasseler Holdings, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Scalpel handle, reusable.

HELMUT ZEPF — Helmut Zepf Medizintechnik GmbH · Class I
KNIFE HANDLE — SONTEC INSTRUMENTS, INC. · Class I
SCALPEL HANDLE #4 — W.H. Holden, Inc. · Class I
Surgical Direct — SURGICAL DIRECT, INC. · Class I
Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
Anterior Disc Prep — SeaSpine Orthopedics Corporation · Class I
HELMUT ZEPF — Helmut Zepf Medizintechnik GmbH · Class I
HANDLE — KLS-Martin L.P. · 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: Peter Brasseler Holdings, LLC

Sources (1)

FDA UDI e88f07be-5b8c-42e9-b204-95f9c85d1c27 33 fields · synced May 31, 2026