General & Plastic Surgery › SurgicalGauze/Sponge, Internal, X-Ray Detectable

Peanut

Peanut 3/8" in Holder

Registry build 21.09.26
67manufacturers in China registered for this device type
2catalogue numbers in this listing
36recalls on this code

Who Else Makes It

Concentrated in Jiangsu (18), Hubei (13), Zhejiang (12). 17 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GDY
Manufacturer City Province Registered as Device types
Shanghai Joy Crown Industry Co., Ltd. Pu Dong New Area Shanghai Contract manufacturer 64
Allmed Medical Products Co., Ltd. Zhijiang Hubei Contract manufacturer 43
BH Medical Products Co., Ltd. Changzhou Jiangsu Contract manufacturer 37
Jiangsu JianYu Health Medical Co., Ltd. Changzhou Jiangsu Contract manufacturer 35
Jiangsu Guangda Medical Material Group Co., Ltd. Haian Jiangsu Contract manufacturer 32
Jingmen Huasheng Asia Dynamics Sanitary Products Co., Ltd. Jingmen Hubei Contract manufacturer 23
Derma Sciences Nantong Incorporation Development Jiangsu Contract manufacturer 19
Kingstar Medical (Xianning) Co., Ltd. Xianning Hubei Contract manufacturer 17
Zhejiang Aoki Medical Dressing Co., Ltd. Wenzhou Zhejiang Contract manufacturer 16
Qingdao Likangyuan Medical Device Co., Ltd. Qingdao Shandong Contract manufacturer 14
Winner Medical (Chongyang) Co., Ltd. Chongyang Hubei Contract manufacturer 13
Suzhou Avon Textile Co., Ltd. Suzhou Jiangsu Contract manufacturer 12

Showing 12 of 67. All 67 manufacturers in China registered for Gauze/Sponge, Internal, X-Ray Detectable

Record

Regulatory record for Peanut
Listed by American Surgical Company, LLC, United States
FDA product code GDY
Device type Gauze/Sponge, Internal, X-Ray Detectable
Device class Class 1
Regulation 21 CFR 878.4450
Establishment Contract manufacturer, Manufacturer
510(k) K872809
Record published 2016-06-30
Record revised 2018-07-06 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Label carries lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Peanut
Catalogue number Size Per pack Status
40-03 40 In distribution
40-03A 40 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
AMD-Ritmed AMD Medicom Inc. 248
DeRoyal Deroyal Industries, Inc. 172
Situate Covidien LP 60
Medical Action Industries Medical Action Industries, Inc. 58
SurgiCount Safety-Sponge Stryker GmbH 50
Dermapac, Inc. Dermapac Inc. 48
Surgicount Stryker GmbH 48
Dukal Dukal LLC 46
Medline Medline Industries, Inc. 41
ORLocate Steris Corporation 35
A Plus A Plus International, Inc 33
Pilling Teleflex Medical LLC 31

Showing 12 of 82. All products under Gauze/Sponge, Internal, X-Ray Detectable

Recalls

36 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated FDA class Root cause Reason Quantity Closed
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 237 units 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 24 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 4 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 23 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 41 Boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 87 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 15 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 13 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 103 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 33 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 25 units 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 155 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 33 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 34 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 262 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 10 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 182 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 37 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 114 cases 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 22 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 54 cases 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 2 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 33 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 6 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 1 box 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 27 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 70 units 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 32 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 45 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 11 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 23 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 39 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 22 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 35 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 37 boxes 2016-10-21
2016-03-31 Class II Packaging process control Product packaging defective compromising sterility 15 boxes 2016-10-21

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