Surgicount
+ SAFE-T-Lap Sponge, 18 inch x 18 inch, RFID, X-Ray, Plastic Ring
67manufacturers in China registered for this device type
48catalogue numbers in this listing
1510(k) clearance
5recalls 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.
| 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
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | GDY |
| Device type | Gauze/Sponge, Internal, X-Ray Detectable |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4450 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-10-07 |
| Record revised | 2022-09-08 (version 4) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment humidity 10 to 90 % RH; Handling environment atmospheric pressure 50 to 106 KiloPascal; Handling environment temperature -20 to 50 °C; Storage environment temperature -20 to 50 °C; Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment humidity 10 to 90 % RH |
| Packaging | Case of 40, pack, case of 64, case of 48, case of 16, case of 20 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 0630002720 | In distribution | ||
| 0632284240 | 10 | In distribution | |
| 0631108360 | 5 | In distribution | |
| 0631318360 | 3 | In distribution | |
| 0622022120 | 8,000 | In distribution | |
| 0623260020 | 400 | In distribution | |
| 0633160050 | 5 | In distribution | |
| 0623360020 | 400 | In distribution | |
| 0631012120 | 5 | In distribution | |
| 0631218180 | 5 | In distribution | |
| 0622284240 | 100 | In distribution | |
| 0633160020 | 2 | In distribution | |
| 0631004180 | 5 | In distribution | |
| 0621012120 | 1,400 | In distribution | |
| 0632284160 | 10 | In distribution | |
| 0621008360 | 800 | In distribution | |
| 0623160020 | 400 | In distribution | |
| 0632022120 | 10 | In distribution | |
| 0623360050 | 400 | In distribution | |
| 0623260050 | 400 | In distribution | |
| 0621118180 | 800 | In distribution | |
| 0621318360 | 399 | In distribution | |
| 0633260050 | 5 | In distribution | |
| 0631008108 | In distribution | ||
| 0622244320 | 1,000 | In distribution | |
| 0630104180 | In distribution | ||
| 0631018180 | 5 | In distribution | |
| 0631118180 | 5 | In distribution | |
| 0632284120 | 10 | In distribution | |
| 0621218180 | 800 | In distribution | |
| 0622284160 | 2,000 | In distribution | |
| 0633260020 | 2 | In distribution | |
| 0630108360 | In distribution | ||
| 0631008360 | 5 | In distribution | |
| 0630002360 | In distribution | ||
| 0633360050 | 5 | In distribution | |
| 0622244160 | 2,000 | In distribution | |
| 0622344160 | 2,000 | In distribution | |
| 0630104360 | In distribution | ||
| 0632244160 | 10 | In distribution | |
| 0623160050 | 400 | In distribution | |
| 0622284120 | 2,000 | In distribution | |
| 0633360020 | 2 | In distribution | |
| 0621108360 | 800 | In distribution | |
| 0621004180 | 1,800 | In distribution | |
| 0621018180 | 800 | In distribution | |
| 0632344160 | 10 | In distribution | |
| 0632244320 | 10 | In distribution |
Same 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 |
| 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 |
| Fabco | First AID Bandage Co Inc | 27 |
Showing 12 of 82. All products under Gauze/Sponge, Internal, X-Ray Detectable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K955599 | 1996-02-22 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2010-01-25 | Not classified | Other | The firm did not have packaging validation to support the labeled shelf life. There is potential for a breach in sterility specific to the sterile packaged femoral sponge which may result in a non-sterile product. | 9,257 all products | 2010-10-25 |
| 2010-01-25 | Not classified | Other | The firm did not have packaging validation to support the labeled shelf life. There is potential for a breach in sterility specific to the sterile packaged femoral sponge which may result in a non-sterile product. | 9,274 all products. | 2010-10-25 |
| 2010-01-25 | Not classified | Other | The firm did not have packaging validation to support the labeled shelf life. There is potential for a breach in sterility specific to the sterile packaged femoral sponge which may result in a non-sterile product. | 9,274 all products | 2010-10-25 |
| 2010-01-25 | Not classified | Other | The firm did not have packaging validation to support the labeled shelf life. There is potential for a breach in sterility specific to the sterile packaged femoral sponge which may result in a non-sterile product. | 9,274 all products. | 2010-10-25 |
| 2010-01-25 | Not classified | Other | The firm did not have packaging validation to support the labeled shelf life. There is potential for a breach in sterility specific to the sterile packaged femoral sponge which may result in a non-sterile product. | 9,274 all products | 2010-10-25 |
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.