IntuBrite

Mac 1/Medium SINGLE USE DISPSOABLE LARYNGOSCOPE SYSTEM. One disposable handle and one disposable blade.

Registry build 21.09.26
44manufacturers in China registered for this device type
61catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (22), Jiangsu (9), Zhejiang (7). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code CCW
Manufacturer City Province Registered as Device types
Flexicare Medical (Dongguan) Ltd. Dongguan Guangdong Contract manufacturer 48
Hangzhou Fushan Medical Appliance Co., Ltd. Hangzhou Zhejiang Contract manufacturer 44
Modern Medical Equipment Manufacturing Ltd. Heng Li, Dongguan Guangdong Contract manufacturer 26
Forefront Medical Technology (Jiangsu) Co., Ltd. Changzhou Jiangsu Contract manufacturer 14
Ambu Limited Xiang Yu F.T.Z., Xiamen Fujian Contract manufacturer 11
Shenzhen Insighters Medical Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 10
Dongguan Honfield Precision Parts Co., Ltd. Zhangmutou, Dongguan Guangdong Contract manufacturer 8
MediConcepts Technology (Shenzhen) Company Limited Shenzhen Guangdong Contract manufacturer 5
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Suzhou Meccan Import and Export Corp. Suzhou Jiangsu Contract manufacturer 71
Saferlife Products Co., Ltd. Guangzhou Guangdong Contract manufacturer 58

Showing 12 of 44. All 44 manufacturers in China registered for Laryngoscope, Rigid

Record

Regulatory record for IntuBrite
Listed by Salter Labs, United States
FDA product code CCW
Device type Laryngoscope, Rigid
Device class Class 1
Regulation 21 CFR 868.5540
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2019-03-18
Record revised 2020-01-27 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date
Packaging Pack of 20, pack of 10

Catalogue Numbers

Catalogue numbers for IntuBrite
Catalogue number Size Status
1021.C.2015.C In distribution
6032.C In distribution
1032.C In distribution
SO-2080 In distribution
6033.C In distribution
1023.C2015.C In distribution
6017.C In distribution
1040.C In distribution
6021.C In distribution
2015.C In distribution
1023.C2017.C In distribution
1022.C In distribution
2010.C In distribution
1030.C In distribution
1031.C2016.C In distribution
6023.C In distribution
2002.C In distribution
1035.C In distribution
6020.C In distribution
1033.C In distribution
1031.C In distribution
1033.C2015.C In distribution
1000 In distribution
1032.C2016.C In distribution
1032.C2017.C In distribution
1010 In distribution
1020.C2016.C In distribution
1035.C2016.C In distribution
1024.C2015.C In distribution
1030.C2016.C In distribution
2011.C In distribution
6031.C In distribution
2017.C In distribution
1039.C2016.C In distribution
1012 In distribution
1022.C2015.C In distribution
1024.C2017.C In distribution
1029.C2015.C In distribution
2016.C In distribution
6034.C In distribution
1024.C In distribution
6035.C In distribution
6022.C In distribution
6039.C In distribution
6015.C In distribution
6040.C In distribution
6029.C In distribution
1021.C In distribution
1021.C2016.C In distribution
1034.C In distribution
6016.C In distribution
1023.C In distribution
1034.C.2017.C In distribution
6030.C In distribution
6024.C In distribution
1039.C In distribution
1020.C In distribution
2001.C In distribution
1022.C2016.C In distribution
1029.C In distribution
1032.C2015.C In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Rusch Teleflex Medical LLC 509
SunMed SunMed Group Holdings, LLC 255
Ambler Surgical Ambler Surgical, LLC 192
AincA® Anesthesia Associates, Inc. 186
Curaplex Bound Tree Medical, LLC 172
GlideScope® Verathon Medical (Canada) ULC 166
Pilling Teleflex Medical LLC 163
Carnegie Surgical LLC Carnegie Surgical LLC 157
Laryngoscope, Rigid Karl Storz GmbH & Co. KG 140
Medline Medline Industries, Inc. 128
Millennium Avalign Technologies, Inc. 111
Sklar® Sklar Corporation 92

Showing 12 of 442. All products under Laryngoscope, Rigid

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