Who else makes this device?

Name: Breiten Sterilization Tray
Brand: Breiten Sterilization Tray

General & Plastic Surgery › SurgicalLight, Surgical, Fiberoptic

Breiten Sterilization Tray

The Breiten Sterilization Tray is intended to allow sterilization of the enclosed medical devices.

Registry build 21.09.26

1manufacturer

2catalogue numbers in this listing

2510(k) clearances naming this product code

Who Else Makes It

Registered in Shandong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code FST
Manufacturer	City	Province	Registered as	Device types
Shandong Weigao Orthopaedic Device Co., Ltd.	Weihai	Shandong	Contract manufacturer	42

Record

Regulatory record for Breiten Sterilization Tray
Listed by	Invuity, Inc., United States
FDA product code	FST
Device type	Light, Surgical, Fiberoptic
Device class	Class 2
Regulation	21 CFR 878.4580
510(k)	K090070
Record published	2016-09-22
Record revised	2023-04-04 (version 8)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Prescription	Prescription only
Latex	Labelled latex-free
Label carries	lot or batch number
Sizes	Width 15 to 23 mm

Catalogue Numbers

Catalogue numbers for Breiten Sterilization Tray
Catalogue number	Size	Status
Narrow	Bracket Width	In distribution
Standard	Width 23 mm	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
System TWO LED	Medical Illumination International, Inc	109
Vu	Medical Illumination International, Inc	48
Maxx Luxx LED	Avante	30
VistOR MS LED	Medical Illumination International, Inc	21
MI Product Line	Medical Illumination International, Inc	20
Vision LED	Avante	18
Fiberoptic Cable	Black & Black Surgical, Inc.	17
MaXcess	Nuvasive, Inc.	17
Integra®	Integra Lifesciences (Ireland) Limited	16
Integra®	Integra LifeSciences Production Corporation	14
Snowden-Pencer	Steris Corporation	11
Vistor PRO LED	Medical Illumination International, Inc	10

Showing 12 of 85. All products under Light, Surgical, Fiberoptic

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K113697	2012-02-10
K090070	2009-04-22

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.