AMD-Ritmed
AMD-RITMED GAUZE PACKING 4 PLY X-RAY DETECTABLE WITH TAPE LOOP 2 X 36 Inch
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 | AMD Medicom Inc., Canada |
|---|---|
| FDA product code | GDY |
| Device type | Gauze/Sponge, Internal, X-Ray Detectable |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4450 |
| Establishment | Specification developer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2019-01-15 |
| Record revised | 2023-09-07 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Cool dry place |
| Packaging | Outer case of 20, outer case of 10, outer case of 40, outer case of 100, outer case of 50, outer case of 240 |
| Distribution end date | 2025-06-03 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1522-10 | 4 X 18 Inch | 2,800 | In distribution |
| 2872 | 2 X 72 Inch | 20 | In distribution |
| 1512 | 18 X 18 Inch | 800 | In distribution |
| 1513 | 18 X 18 Inch | 200 | In distribution |
| 1511-MR | 18 X 18 Inch | 400 | In distribution |
| 73512 | 9/16 X 1/4 Inch | 5 | In distribution |
| 1503 | 1 X 1 Inch | 200 | In distribution |
| MEX-5400GX | 16 X 26 Inch | 400 | In distribution |
| 1505-NL | 12 X 12 Inch | 5 | In distribution |
| 55994C | 1/2 X 3 Inch | 100 | In distribution |
| 1526 | 4 X 18 Inch | 5 | In distribution |
| 1511-NL | 18 X 18 Inch | 800 | In distribution |
| 58913 | 1 Inch | 500 | In distribution |
| 55998C | 1/2 X 1 1/2 Inch | 100 | In distribution |
| 1516 | 18 X 18 Inch | 5 | In distribution |
| 1515R | 18 X 18 Inch | 5 | In distribution |
| 55996C | 1 X 1 Inch | 100 | In distribution |
| 1522 | 4 X 18 Inch | 2,800 | In distribution |
| 85996C | 1 X 1 Inch | 10 | In distribution |
| 5004-WX | 4 | In distribution | |
| 5002-WX | 2 | In distribution | |
| 84442 | 2 X 36 Inch | In distribution | |
| 85997C | 1 X 3 Inch | 10 | In distribution |
| 1515-T | 18 X 18 Inch | 5 | In distribution |
| 74712X | 3/8 Inch | 5 | In distribution |
| MEX-5400WX | 16 X 26 Inch | 400 | In distribution |
| 1521-NL | 4 X 18 Inch | 2,800 | In distribution |
| 1561K | 17 X 26 Inch | 400 | In distribution |
| 85992C | 1/2 X 1/2 Inch | 10 | In distribution |
| 1525 | 4 X 18 Inch | 5 | In distribution |
| 1525-T | 4 X 18 Inch | 5 | In distribution |
| 1511 | 18 X 18 Inch | 800 | In distribution |
| 5002-BX | 2 | In distribution | |
| 85995C | 3/4 X 3/4 Inch | 10 | In distribution |
| 1501-ROLL | 12 X 12 Inch | 1,400 | In distribution |
| 78912 | 7/8 Inch | 5 | In distribution |
| 6128 | 8 X 4 Inch | 10 | In distribution |
| 1524 | 4 X 18 Inch | 200 | In distribution |
| 1523 | 4 X 18 Inch | 200 | In distribution |
| 1505-T | 12 X 12 Inch | 5 | In distribution |
| 1514 | 18 X 18 Inch | 200 | In distribution |
| 85998C | 1/2 X 1 1/2 Inch | 10 | In distribution |
| 55995C | 3/4 X 3/4 Inch | 100 | In distribution |
| 1504 | 12 X 12 Inch | 200 | In distribution |
| 1521-PR | 4 X 18 Inch | 1,000 | In distribution |
| 55997C | 1 X 3 Inch | 100 | In distribution |
| 55992C | 1/2 X 1/2 Inch | 100 | In distribution |
| 78914 | 1 Inch | 5 | In distribution |
| 1501 | 12 X 12 Inch | 1,400 | In distribution |
| 1531 | 8 X 36 Inch | 800 | In distribution |
| 85994C | 1/2 X 3 Inch | 10 | In distribution |
| 74712 | 3/8 Inch | 5 | In distribution |
| 85993C | 1/2 X 1 Inch | 10 | In distribution |
| 1502 | 12 X 12 Inch | 1,400 | In distribution |
| 1515 | 18 X 18 Inch | 5 | In distribution |
| 1505 | 12 X 12 Inch | 5 | In distribution |
| 1503V | In distribution | ||
| 1521 | 4 X 18 Inch | 2,800 | In distribution |
| 1501-PR | 12 X 12 Inch | 700 | In distribution |
| 5006-GX | 6 | In distribution | |
| 1501-NL | 12 X 12 Inch | 1,400 | In distribution |
| 5004-BX | 4 | In distribution | |
| 5002-GX | 2 | In distribution | |
| 1511-PR | 18 X 18 Inch | 400 | In distribution |
| 1515NL | 18 X 18 Inch | 5 | In distribution |
| 55993C | 1/2 X 1 Inch | 100 | In distribution |
| 1506 | 12 X 12 Inch | 5 | In distribution |
| 85941 | 3/4 X 3/4 Inch | 10 | Withdrawn |
| 21006 | 1/2 X 1 Inch | 200 | Withdrawn |
| 83242 | 3/8 X 1 Inch | 5 | Withdrawn |
| 85960 | 1 1/2 X 6 Inch | 10 | Withdrawn |
| 1006 | 1/2 X 1 Inch | 10 | Withdrawn |
| 1004S | 1 X 3 Inch | 10 | Withdrawn |
| 53243-S | 3/8 X 1 1/2 Inch | 500 | Withdrawn |
| 54422 | 1 Inch X 100 Yard | Withdrawn | |
| 73212 | 3/8 X 1/4 Inch | 5 | Withdrawn |
| 21001 | 3/4 X 3/4 Inch | 200 | Withdrawn |
| 58913A-S | 1 Inch | 500 | Withdrawn |
| 84440 | 2 X 2 Inch | 5 | Withdrawn |
| 89908C | 3 X 6 Inch | 10 | Withdrawn |
| 21003 | 1/2 X 3 Inch | 200 | Withdrawn |
| 2872S | 2 X 72 Inch | Withdrawn | |
| 85931 | 1 X 3 Inch | 10 | Withdrawn |
| 6109 | 8 X 4 Inch | 10 | Withdrawn |
| 1541-3 | 18 X 36 Inch | 240 | Withdrawn |
| 85999C | 1/2 X 2 Inch | 10 | Withdrawn |
| 1535 | 8 X 36 Inch | 5 | Withdrawn |
| 1510-C | 0.25 Inch | 250 | Withdrawn |
| 1003 | 1/2 X 3 Inch | 10 | Withdrawn |
| 89907C | 1 X 6 Inch | 10 | Withdrawn |
| 1300 | 1/2 X 6 Inch | 10 | Withdrawn |
| 55936 | 1/2 X 3 Inch | 100 | Withdrawn |
| 58694 | 1 1/4 Inch | 2,000 | Withdrawn |
| 58917VS | 1 1/2 Inch | 1,000 | Withdrawn |
| 85912C | 2 X 6 Inch | 10 | Withdrawn |
| 1504-C | 1 Inch | 5 | Withdrawn |
| 55999C | 1/2 X 2 Inch | 100 | Withdrawn |
| 74732 | 1/2 Inch | 5 | Withdrawn |
| 54425 | 2 X 36 Inch | 100 | Withdrawn |
| 83841 | 1 1/4 Inch | 5 | Withdrawn |
| 1514-C | 1 Inch | 250 | Withdrawn |
| 73514 | 9/16 X 1/8 Inch | 5 | Withdrawn |
| 1500-C | 0.25 Inch | 5 | Withdrawn |
| 53221 | 3/8 X 1 1/2 Inch | 500 | Withdrawn |
| 21000 | 1/2 X 1/2 Inch | 200 | Withdrawn |
| 55922C | 3/4 X 3 Inch | 100 | Withdrawn |
| 1003S | 1/2 X 3 Inch | 10 | Withdrawn |
| 1511-C | 3/8 Inch | 250 | Withdrawn |
| 58911 | 7/8 Inch | 500 | Withdrawn |
| 64461 | 2 X 2 Inch | 100 | Withdrawn |
| 1005S | 1/2 X 1 1/2 Inch | 10 | Withdrawn |
| 76524 | 1/2 X 2 Inch | 5 | Withdrawn |
| 55921C | 1/4 X 3 Inch | 100 | Withdrawn |
| 89910C | 1/2 X 6 Inch | 10 | Withdrawn |
| 78682 | 7/8 Inch | 5 | Withdrawn |
| 59915C | 1/4 X 6 Inch | 100 | Withdrawn |
| 1518-C | 1/8 Inch | 250 | Withdrawn |
| 1007 | 1 1/2 X 1 1/2 Inch | 10 | Withdrawn |
| 1502-C | 0.5 Inch | 5 | Withdrawn |
| 21005 | 1/2 X 1 1/2 Inch | 200 | Withdrawn |
| 59213 | 3 X 12 Inch | 100 | Withdrawn |
| 2872-PT | 2 X 72 Inch | 100 | Withdrawn |
| 1004 | 1 X 3 Inch | 10 | Withdrawn |
| 53217 | 3/8 X 3/4 Inch | 500 | Withdrawn |
| 9004 | 1 Inch | 5 | Withdrawn |
| 54423 | 2 Inch X 100 Yard | Withdrawn | |
| 55903C | 1/4 X 1 1/4 Inch | 100 | Withdrawn |
| 1306 | 1 X 6 Inch | 10 | Withdrawn |
| 1513-C | 0.75 Inch | 250 | Withdrawn |
| 83850 | 1 Inch | 5 | Withdrawn |
| MEX-5400BX | 16 X 26 Inch | 400 | Withdrawn |
| 78913 | 3/4 Inch | 5 | Withdrawn |
| 88682 | 1 Inch | 5 | Withdrawn |
| 53243 | 3/8 X 1 1/2 Inch | 500 | Withdrawn |
| 6129 | 8 X 4 Inch | 10 | Withdrawn |
| 1000-AD | 1/2 X 1/2 Inch | 10 | Withdrawn |
| 85991C | 1/4 X 1/4 Inch | 10 | Withdrawn |
| 59907C | 1 X 6 Inch | 100 | Withdrawn |
| 85943 | 3/4 X 3 Inch | 10 | Withdrawn |
| 58915V | 1 1/4 Inch | 2,000 | Withdrawn |
| 59912C | 2 X 6 Inch | 100 | Withdrawn |
| 85959 | 2 X 6 Inch | 10 | Withdrawn |
| 73222 | 3/8 X 1 1/2 Inch | 5 | Withdrawn |
| 85911C | 1 1/2 X 6 Inch | 10 | Withdrawn |
| 6125 | 4 x 4 Inch | 10 | Withdrawn |
| 73224 | 1/2 X 1 1/2 Inch | 5 | Withdrawn |
| 1505-C | 1.25 Inch | 5 | Withdrawn |
| 76526 | 1/2 X 4 Inch | 5 | Withdrawn |
| 83846 | 1 Inch | 5 | Withdrawn |
| 84442L | 2 X 36 Inch | Withdrawn | |
| 83522 | 1 X 1/4 Inch | 5 | Withdrawn |
| 83842 | 1/4 Inch | 5 | Withdrawn |
| 85940C | 3 X 3 Inch | 10 | Withdrawn |
| 53219 | 3/8 X 1 Inch | 500 | Withdrawn |
| 1304 | 3 X 6 Inch | 10 | Withdrawn |
| 1008 | 3 X 3 Inch | 10 | Withdrawn |
| 85939 | 1/2 X 1 Inch | 10 | Withdrawn |
| 54426 | 2 X 36 Inch | 100 | Withdrawn |
| 21005-AD | 1/2 X 1 1/2 Inch | 200 | Withdrawn |
| 53511 | 9/16 X 1/4 Inch | 500 | Withdrawn |
| 83246 | 1/2 X 1 1/2 Inch | 5 | Withdrawn |
| 21003-AD | 1/2 X 3 Inch | 200 | Withdrawn |
| 83250 | 3/8 X 3/8 Inch | 5 | Withdrawn |
| 83248 | 1/2 X 2 Inch | 5 | Withdrawn |
| 6102 | 2 X 2 Inch | 10 | Withdrawn |
| 54403 | 2 X 14 Inch | 100 | Withdrawn |
| 1533 | 8 X 36 Inch | 200 | Withdrawn |
| 85935 | 1/2 X 1 1/2 Inch | 10 | Withdrawn |
| 78672 | 1 1/4 Inch | 5 | Withdrawn |
| 59910C | 1/2 X 6 Inch | 100 | Withdrawn |
| 55991C | 1/4 X 1/4 Inch | 100 | Withdrawn |
| 54413 | 2 X 2 Inch | 100 | Withdrawn |
| 53217-S | 3/8 X 3/4 Inch | 500 | Withdrawn |
| 78926T | 3/4 X 1 1/2 Inch | 5 | Withdrawn |
| 84414 | 2 X 2 Inch | 5 | Withdrawn |
| 84444 | 1 X 36 Inch | 5 | Withdrawn |
| 84416 | 3 X 3 Inch | 5 | Withdrawn |
| 58919V | 1 3/8 Inch | 1,000 | Withdrawn |
| 58913A | 1 Inch | 500 | Withdrawn |
| 58917V | 1 1/2 Inch | 1,000 | Withdrawn |
| 59211X | 4 1/2 X 1 1/4 Inch | 100 | Withdrawn |
| 55923C | 3 X 3 Inch | 100 | Withdrawn |
| 6125NS | 4 x 4 Inch | 100 | Withdrawn |
| 85936C | 1/4 X 3 Inch | 10 | Withdrawn |
| 58917-10S | 1 1/4 Inch | 500 | Withdrawn |
| 89915C | 1/4 X 6 Inch | 10 | Withdrawn |
| 9005 | 1 1/4 Inch | 5 | Withdrawn |
| 73224A | 1/2 X 1 1/2 Inch | 5 | Withdrawn |
| 1503-C | 0.75 Inch | 5 | Withdrawn |
| 88692 | 1 1/2 Inch | 5 | Withdrawn |
| 83516 | 1 X 1/4 Inch | 5 | Withdrawn |
| 78916 | 1 1/4 Inch | 5 | Withdrawn |
| 85966 | 3 X 6 Inch | 10 | Withdrawn |
| 1000S | 1/2 X 1/2 Inch | 10 | Withdrawn |
| 85978 | 1/2 X 6 Inch | 10 | Withdrawn |
| 85904 | 1/2 X 1/2 Inch | 10 | Withdrawn |
| 54415 | 3 X 3 Inch | 100 | Withdrawn |
| 53245 | 1/2 X 1 1/2 Inch | 500 | Withdrawn |
| 1545 | 18 X 36 Inch | 2 | Withdrawn |
| 83244 | 3/8 X 1 1/2 Inch | 5 | Withdrawn |
| 84446 | 2 X 108 Inch | Withdrawn | |
| 1001S | 3/4 X 3/4 Inch | 10 | Withdrawn |
| 9013 | 3/4 Inch | 250 | Withdrawn |
| 84418 | 4 X 4 Inch | 5 | Withdrawn |
| 58692 | 1 Inch | 2,000 | Withdrawn |
| 21008 | 3 X 3 Inch | 200 | Withdrawn |
| 1005 | 1/2 X 1 1/2 Inch | 10 | Withdrawn |
| 59909C | 3/4 X 6 Inch | 100 | Withdrawn |
| 1501-C | 3/8 Inch | 5 | Withdrawn |
| 85938C | 3/4 X 3 Inch | 10 | Withdrawn |
| 1004-AD | 1 X 3 Inch | 10 | Withdrawn |
| 85927 | 1 X 1 Inch | 10 | Withdrawn |
| 85937 | 1/2 X 3 Inch | 10 | Withdrawn |
| 85980 | 3/4 X 6 Inch | 10 | Withdrawn |
| 83867XR | 1/8 Inch | 5 | Withdrawn |
| 89909C | 3/4 X 6 Inch | 10 | Withdrawn |
| 1757H | 3/8 X 1/4 Inch | 5 | Withdrawn |
| 84403 | 2 X 14 Inch | Withdrawn | |
| 84412 | 2 X 2 Inch | 5 | Withdrawn |
| 83560 | 1/4 Inch | 5 | Withdrawn |
| 84439 | 1/4 X 22 Inch | Withdrawn | |
| 73218 | 3/8 X 3/4 Inch | 5 | Withdrawn |
| 59914C | 3 1/2 X 6 Inch | 100 | Withdrawn |
| 53221-S | 3/8 X 1 1/2 Inch | 500 | Withdrawn |
| 21002 | 1 X 1 Inch | 200 | Withdrawn |
| 1508-C | 1/8 Inch | 5 | Withdrawn |
| 59911C | 1 1/2 X 6 Inch | 100 | Withdrawn |
| G55901 | 1/4 X 1/4 Inch | 10 | Withdrawn |
| 55930 | 1 X 3 Inch | 100 | Withdrawn |
| 84722 | 3/8 Inch | 5 | Withdrawn |
| 73220 | 3/8 X 1 Inch | 5 | Withdrawn |
| 9003 | 0.75 Inch | 5 | Withdrawn |
| 54417 | 4 X 4 Inch | 100 | Withdrawn |
| 59908C | 3 X 6 Inch | 100 | Withdrawn |
| 85974 | 3 X 3 Inch | 10 | Withdrawn |
| 21004 | 1 X 3 Inch | 200 | Withdrawn |
| 1000 | 1/2 X 1/2 Inch | 10 | Withdrawn |
| 1001 | 3/4 X 3/4 Inch | 10 | Withdrawn |
| 1506-C | 2 Inch | 5 | Withdrawn |
| 54419 | 8 X 4 Inch | 100 | Withdrawn |
| 1002 | 1 X 1 Inch | 10 | Withdrawn |
| 54417A | 4 X 4 Inch | 100 | Withdrawn |
| 58913S | 1 Inch | 500 | Withdrawn |
| 84458 | 8 X 4 Inch | Withdrawn | |
| 6108-5 | 8 X 4 Inch | 5 | Withdrawn |
| 1512-C | 1/2 Inch | 250 | Withdrawn |
| 84423A | 2 X 120 Inch | Withdrawn | |
| 76522 | 1/2 X 2 Inch | 5 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Fabco | First AID Bandage Co Inc | 27 |
Showing 12 of 82. All products under Gauze/Sponge, Internal, X-Ray Detectable
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| AMD Medicom Inc. | UDI-DI | 2026-05-08 | Class II | Material/Component Contamination | Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not consistently meet endotoxin specification for devices that contact the cerebrospi | 7,838,200 |
| AMD Medicom Inc. | UDI-DI | 2026-05-08 | Class II | Material/Component Contamination | Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not consistently meet endotoxin specification for devices that contact the cerebrospi | 10 |
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.