ACE

6' Diss Swivel TO Puritan Male Nitrous Oxide Hose Assy. Blue 6' Diss Swivel TO Puritan Male

Registry build 21.09.26
4manufacturers in China registered for this device type
14catalogue numbers in this listing

Who Else Makes It

Concentrated in Shandong (1), Jiangsu (1), Beijing (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code GDR
Manufacturer City Province Registered as Device types
B.Braun Medical (Suzhou) Co,.Ltd Suzhou Jiangsu Contract manufacturer 37
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Beijing Fule Science & Technology Development Co., Ltd. Beijing Beijing Manufacturer 31
Shenzhen Airgle Corporation Limited Shenzhen Guangdong Manufacturer 4

Record

Regulatory record for ACE
Listed by Ace Surgical Supply Co., Inc., United States
FDA product code GDR
Device type Saw, Manual And Accessories
Device class Class 1
Regulation 21 CFR 878.4800
Premarket notification Exempt
Record published 2019-10-16
Record revised 2022-08-05 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number
Storage Special storage condition: No special storage conditions required
Sizes Length 6 ft; length 36 in
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for ACE
Catalogue number Size Status
5231222 Length 6 ft In distribution
0031206 Length 6 ft In distribution
1031090 Length 36 in In distribution
5231234 Length 6 ft In distribution
5231231 Length 6 ft In distribution
5231229 Length 6 ft In distribution
5231235 Length 6 ft In distribution
5231230 Length 6 ft In distribution
1031100 Length 36 in In distribution
5231221 Length 6 ft In distribution
5231220 Length 6 ft In distribution
0031205 Length 6 ft In distribution
5231228 Length 6 ft In distribution
5231223 Length 6 ft In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Ambler Surgical Ambler Surgical, LLC 23
Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft 20
Aesculap Aesculap AG 19
gSource Gsource, LLC. 16
Integra® Miltex® Integra LifeSciences Production Corporation 14
Boss Instruments Boss Instruments, Ltd. 11
RZ Medizintechnik GmbH RZ Medizintechnik Gmbh 11
Integra® Jarit® Integra LifeSciences Production Corporation 10
Novo Surgical Inc. Novo Surgical, Inc. 10
Integra® Ruggles®-Redmond™ Integra LifeSciences Production Corporation 10
Kmedic Teleflex Medical LLC 8
Millennium Avalign Technologies, Inc. 7

Showing 12 of 46. All products under Saw, Manual And Accessories

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer