Optics ONE

Combo C-arm Cover with Band Bag 44 x 77(c-arm)-36x30(Bandbag)

Registry build 21.09.26
39manufacturers in China registered for this device type
60catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (14), Zhejiang (6), Guangdong (6). 21 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KKX
Manufacturer City Province Registered as Device types
GRI Medical & Electronic Technology Co., Ltd. Jiaxing Zhejiang Contract manufacturer 71
Suzhou Meccan Import and Export Corp. Suzhou Jiangsu Contract manufacturer 71
Principle & Will Biotech (Pinghu) Co., Ltd. Pinghu Zhejiang Contract manufacturer 39
Dongguan Shin YI Healthcare Products Factory Dong Guan Guangdong Contract manufacturer 30
Exact Medical Manufacturing, Inc. Changzhou Jiangsu Contract manufacturer 17
Jiangsu Likang Medical Products Co., Ltd. Wujiang Jiangsu Contract manufacturer 17
Changzhou Holymed Products Co., Ltd. Changzhou Jiangsu Contract manufacturer 16
Xiantao Daoqi Plastic Co., Ltd. Xiantao Hubei Contract manufacturer 16
Heyuan Hong DE Medical Products Co., Ltd. Heyuan Guangdong Contract manufacturer 13
Wuhan Huaxin Nonwoven Co., Ltd. Wuhan Hubei Contract manufacturer 13
Foshan Nanhai Plus Medical Co Ltd Foshan Guangdong Contract manufacturer 12
Kunshan Jiehong Nonwoven Product Co., Ltd. Kunshan Jiangsu Contract manufacturer 12

Showing 12 of 39. All 39 manufacturers in China registered for Drape, Surgical, Antimicrobial

Record

Regulatory record for Optics ONE
Listed by Medical Technique, Inc.
FDA product code KKX
Device type Drape, Surgical, Antimicrobial
Device class Class 2
Regulation 21 CFR 878.4370
Premarket notification Exempt
Record published 2016-09-23
Record revised 2018-03-29 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Ethylene Oxide
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Latex Labelled latex-free
Label carries lot or batch number, expiry date
Packaging Case of 2, inner pack of 10, case of 20, case of 50, case of 25, inner pack of 20

Catalogue Numbers

Catalogue numbers for Optics ONE
Catalogue number Size Status
1288-20 In distribution
4746-20 In distribution
DB0022S In distribution
9999-80 In distribution
1292-20 In distribution
4337-20 In distribution
4339-20 In distribution
VPC0548 In distribution
VPC0648 In distribution
3279-50 In distribution
1012-40 In distribution
4705-40 In distribution
9975-14 In distribution
1215-ZIP In distribution
9951-20NS In distribution
G1292-20 In distribution
8900-96NS In distribution
9927-NS In distribution
G1289-20 In distribution
9998-50 In distribution
9955-50NS In distribution
9951-20 In distribution
BB3630RT In distribution
8904-96 In distribution
4338-20 In distribution
DB0018S In distribution
G1290-20 In distribution
9414-40 In distribution
BB3020R In distribution
9974-14 In distribution
1290-20 In distribution
8901-96 In distribution
MTI-001 In distribution
1289-20 In distribution
9997-20 In distribution
8900-96 In distribution
9956-50 In distribution
9961-12 In distribution
BB4040RT In distribution
VPC0596 In distribution
1295-20 In distribution
4336-20 In distribution
9954-50 In distribution
8905-96 In distribution
G1295-20 In distribution
9965-NS In distribution
4951-20 In distribution
VPC0696 In distribution
BB3636RT In distribution
9926-NS In distribution
G1303-20 In distribution
2722 In distribution
MTI-0160 In distribution
DB0014S In distribution
BB3620R In distribution
BB3030R In distribution
MTI-0020 In distribution
DB0026S In distribution
9955-50 In distribution
9956-50NS In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Microtek Microtek Medical LLC 994
Exact Medical Manufacturing, Inc. Exact Medical Manufacturing, Inc. 819
Halyard O&M Halyard, Inc. 800
Medline Medline Industries, Inc. 517
Convertors Cardinal Health 200, LLC 392
Medline Industries, Inc. Medline Industries, Inc. 274
TIDIShield Tidi Products, LLC 187
DeRoyal Deroyal Industries, Inc. 118
Cardinal Health Cardinal Health 200, LLC 111
Angiosystems Drape Angiosystems, Inc. 109
ComPel Surgical Drape Standard Textile Co., Inc. 101
Drape, Surgical, Antimicrobial Welmed, Inc. 95

Showing 12 of 329. All products under Drape, Surgical, Antimicrobial

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