Henry Schein

Pro Sphyg/Sprague Kit, Adult, Royal Blue

Registry build 21.09.26
64manufacturers in China registered for this device type
20catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (26), Jiangsu (13), Shanghai (7). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LDE
Manufacturer City Province Registered as Device types
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Wenzhou Caretek Medical Device Co., Ltd. Wenzhou Zhejiang Contract manufacturer 30
Jiangsu Yuyue Medical Equipment & Supply Company Limited Jiangsu Jiangsu Contract manufacturer 17
Honsun (Nantong) Co., Ltd. Nantong Jiangsu Contract manufacturer 9
Vapo Healthcare Co., Ltd. Suzhou Jiangsu Contract manufacturer 9
Xiantao Junhui Plastic Products Co., Ltd. Xiantao Hubei Contract manufacturer 7
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Hospital & Homecare IMP. & EXP. Co., Ltd. Nanjing Jiangsu Contract manufacturer 179
Jiangsu NEW Pentastar Medical Products Co., Ltd. Changzhou Jiangsu Exporter 146
Huzhou Junda Industry Co., Ltd. Anji Zhejiang Contract manufacturer 129
Zhejiang Mediunion Healthcare Group Co., Ltd. Ningbo Zhejiang Contract manufacturer 105
Shanghai Jolly Industrial Co., Ltd. Shanghai Shanghai Contract manufacturer 99

Showing 12 of 64. All 64 manufacturers in China registered for Stethoscope, Manual

Record

Regulatory record for Henry Schein
Listed by Henry Schein, Inc., United States
FDA product code LDE
Device type Stethoscope, Manual
Device class Class 1
Regulation 21 CFR 870.1875
Premarket notification Exempt
Record published 2019-02-13
Record revised 2024-11-25 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Over the counter Yes
Supplied as a kit Yes
Latex Labelled latex-free
Label carries lot or batch number
Storage Storage environment temperature -4 to 131 °F; Storage environment humidity 15 to 85 % RH
Packaging Case of 50, case of 20, case of 10, case of 5, master case of 12
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Henry Schein
Catalogue number Size Status
9004820 In distribution
9004810 In distribution
9004817 In distribution
9007457 In distribution
9004816 In distribution
9004821 In distribution
9004822 In distribution
9004819 In distribution
9004823 In distribution
9004812 In distribution
9004811 In distribution
9004825 In distribution
9004824 In distribution
9004826 In distribution
9004809 In distribution
9004818 In distribution
1126777 In distribution
1126781 Adult, 23-40cm In distribution
9004815 In distribution
9004813 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Adscope® American Diagnostic Corp. 737
Proscope™ American Diagnostic Corp. 292
MDF® MDF Instruments Medifriend Inc. 226
Stethoscope Rashman Corp. 185
3M™ Littmann® 3M Company 118
3M™ Littmann® Classic III™ 3M Company 84
Cardinal Health Cardinal Health 200, LLC 79
3M™ Littmann® Cardiology IV™ 3M Company 78
Sklar® Sklar Corporation 55
Welch Allyn, Inc. Welch Allyn, Inc. 53
MediChoice Owens & Minor Distribution, Inc. 48
Labtron GF Health Products, Inc 45

Showing 12 of 165. All products under Stethoscope, Manual

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