ORLocate

ORLocate RFID Tonsil Sponge, Double Strung, X-Ray, 0.875 inch diameter, Sterile is used with the ORLocate Sponge Solution System.

Registry build 21.09.26
67manufacturers in China registered for this device type
35catalogue numbers in this listing

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 ORLocate
Listed by Steris Corporation, 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, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2022-12-07
Record revised 2025-04-24 (version 2)

Specifications

Specifications
MRI safety MR Unsafe
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date
Packaging Case of 100, case of 40, case of 3, case of 20, pack of 40, case of 128
Sizes Width 2 to 18 in; length 2 to 96 in; outer diameter 0.75 to 1.5 in; length 5 Yard

Catalogue Numbers

Catalogue numbers for ORLocate
Catalogue number Size Per pack Status
ORLocate Lap Sponge Length 36 in 5 In distribution
ORLocate Lap Sponge Length 18 in 5 In distribution
ORLocate Lap Sponge Width 12 in 5 In distribution
ORLocate Lap Sponge Width 18 in 5 In distribution
ORLocate Towel 100 In distribution
ORLocate Vaginal Packing Length 36 in In distribution
ORLocate Towel 100 In distribution
ORLocate Lap Sponge Length 18 in 5 In distribution
ORLocate Gauze Width 4 in 10 In distribution
ORLocate Towel 4 In distribution
ORLocate Lap Sponge Length 18 in 10 In distribution
ORLocate Tonsil Sponge Outer Diameter 0.875 in 5 In distribution
ORLocate Tonsil Sponge Outer Diameter 1 in 5 In distribution
ORLocate Gauze Length 4 in 10 In distribution
ORLocate Tonsil Sponge Outer Diameter 1.5 in 5 In distribution
ORLocate Tonsil Sponge Outer Diameter 1.25 in 5 In distribution
ORLocate Gauze Width 8 in 10 In distribution
ORLocate Tonsil Sponge Outer Diameter 1 in 5 In distribution
ORLocate Towel 4 In distribution
ORLocate Lap Sponge Length 36 in 5 In distribution
ORLocate Lap Sponge Length 18 in 5 In distribution
ORLocate Lap Sponge Length 26 in 5 In distribution
ORLocate Gauze Length 4 in 10 In distribution
ORLocate Vaginal Packing Width 4 in 240 In distribution
ORLocate Gauze Length 4 in 10 In distribution
ORLocate Lap Sponge 5 In distribution
ORLocate Gauze Width 2 in 10 In distribution
ORLocate Lap Sponge Width 4 in 5 In distribution
ORLocate Tonsil Sponge Outer Diameter 1.25 in 5 In distribution
ORLocate Tonsil Sponge Outer Diameter 0.75 in 5 In distribution
ORLocate Vaginal Packing Length 5 Yard In distribution
ORLocate Vaginal Packing Length 72 in 5 In distribution
ORLocate Tonsil Sponge Outer Diameter 0.875 in 5 In distribution
ORLocate Vaginal Packing Length 96 in In distribution
ORLocate Gauze Length 2 in 10 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
A Plus A Plus International, Inc 33
Pilling Teleflex Medical LLC 31
Fabco First AID Bandage Co Inc 27

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

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