Brasseler USA

FDA UDI

Class I (US FDA UDI)

by Peter Brasseler Holdings, LLC

Identity

Trade Name: Brasseler USA FDA UDI
Generic Name: Surgical instrument maintenance lubricant FDA UDI
Device Name: ENDOSYNC OIL 60ML 1P FDA UDI
Model / Reference: 5025559U0 FDA UDI
Description: ENDOSYNC OIL 60ML 1P FDA UDI

Identifiers

Primary DI / UDI-DI: 00887919762164 FDA UDI
510(k) Number: K173920 FDA UDI
FDA Product Code: EKX FDA UDI
GMDN Term: Surgical instrument maintenance lubricant FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4200 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

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical instrument maintenance lubricant

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

Similar devices

Also classified as Surgical instrument maintenance lubricant.

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Sklar® — Sklar Corporation · Class I
ContraClean — Stryker Corp. · Class I
CURVTEK LUBRICANT, 1OZ — Biomet Orthopedics, Inc. · Class I
Sky-Lube — Skytron, LLC · Class II
Primado2 — NAKANISHI INC. · Class I
Surgical Milk — Germiphene Corp. · Class I
PREMIXSLIP (4.2oz/125ml with mister) — Ruhof Corporation · Class I

Cleared under the same submission

K173920 also covers:

LS OIL — J.MORITA MFG.CORP.

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

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Manufacturer

Manufacturer: Peter Brasseler Holdings, LLC

Sources (1)

FDA UDI fce32776-3157-497a-9a70-a67578a71c57 34 fields · synced May 30, 2026