What is FDA product code OFX?

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Dental › MiscellaneousGeneral Purpose Dental Tray

Cool Cassette 10 Instrument Container Blue

Name: Cool Cassette 10 Instrument Container Blue
Brand: Cool Cassette 10 Instrument Container Blue

Catalogue number 7039771 BLU, listed by Practicon, Inc., United States, under General Purpose Dental Tray. 7 manufacturers in China are registered for this product code.

Registry build 21.09.26

7manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Shanghai (2), Zhejiang (1), Anhui (1).

Chinese manufacturers registered for FDA product code OFX
Manufacturer	City	Province	Registered as	Device types
Shanghai Jolly Industrial Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	99
Shanghai Lions Industrial Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	82
Ningbo Greetmed Medical Instruments Co., Ltd.	Ningbo	Zhejiang	Specification developer	75
TF NEW Material SCI AND TEC Co., Ltd.	Huainan	Anhui	Manufacturer	51
Hubei Lanbin Medical Group Co., Ltd.	Xiaogan	Hubei	Contract manufacturer	33
CDM Center OF Excellence Ltd.	Beijing	Beijing	Manufacturer	29
Henan Lusterdent Medical Instrument Co., Ltd.	Zhengzhou	Henan	Manufacturer	15

Record

Regulatory record for Cool Cassette 10 Instrument Container Blue
Listed by	Practicon, Inc., United States
FDA product code	OFX
Device type	General Purpose Dental Tray
Device class	Class 1
Regulation	21 CFR 872.6640
Establishment	Specification developer, Repacker / relabeller, Manufacturer
Premarket notification	Exempt
Record published	2018-07-20
Record revised	2022-09-16 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization

Catalogue Numbers

Catalogue numbers for Cool Cassette 10 Instrument Container Blue
Catalogue number	Size	Status
7039771 BLU		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Cardinal Health	Cardinal Health 200, LLC	813
Medline Industries, Inc.	Medline Industries, Inc.	287
Stradis Healthcare	Stradis Healthcare	69
Stradis	Stradis Healthcare	44
Aligned Medical Solutions	Aligned Medical Solutions	25
ACS	American Contract Systems, Inc.	25
Centurion	Centurion Medical Products Corporation	21
Medical Action Industries	Medical Action Industries, Inc.	10
Centurion Medical Products Corp	Medline Industries, Inc.	9
Brasseler USA	Peter Brasseler Holdings, LLC	4
DeRoyal	Deroyal Industries, Inc.	3
Regard™	ROi CPS LLC	2

Showing 12 of 46. All products under General Purpose Dental Tray

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.