Situate
Gauze-RF and X-ray Detectable USP Type VII, 12 Ply. Caution: For Manufacturing, Processing or Repacking.
67manufacturers in China registered for this device type
60catalogue 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.
| 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 | Covidien LP, United States |
|---|---|
| FDA product code | GDY |
| Device type | Gauze/Sponge, Internal, X-Ray Detectable |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4450 |
| Premarket notification | Exempt |
| Record published | 2018-09-24 |
| Record revised | 2025-12-23 (version 16) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Handling environment temperature -22 to 140 °F; Storage environment atmospheric pressure 70 to 106 KiloPascal; Handling environment atmospheric pressure 50 to 106 KiloPascal; Handling environment humidity 10 to 90 % RH; Storage environment humidity 20 to 90 % RH; Storage environment temperature 50 to 104 °F |
| Packaging | Case of 100, case of 2, case of 40, case of 200, case of 3, case of 80 |
| Sizes | Width 2 to 18 in; length 2 to 96 in; outer diameter 0.75 to 1.5 in |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| TSD-1250C-1 | Outer Diameter 1.25 in | 5 | In distribution |
| G0303-12P01CN-1 | Width 3 in | 2,000 | In distribution |
| L1212-04P01C-1 | Length 12 in | 5 | In distribution |
| G0804-24P02C-1 | Length 4 in | 10 | In distribution |
| L1836-04P01C-1 | Length 36 in | 5 | In distribution |
| L0418-04P01CN-1 | Length 18 in | 1,120 | In distribution |
| TOR-0101CN-1 | 400 | In distribution | |
| G0804-16P02CN-1 | Width 8 in | 800 | In distribution |
| VPK-0472C-F | Width 4 in | In distribution | |
| L1818-04P01C-1 | Length 18 in | 5 | In distribution |
| G0804-12P02C-1 | Length 4 in | 10 | In distribution |
| G0804-32P02C-1 | Length 4 in | 10 | In distribution |
| TORW-0101CN-1 | 400 | In distribution | |
| L1212-04P01CN-1 | Length 12 in | 560 | In distribution |
| G0202-08P01CN-1 | Width 2 in | 10 | In distribution |
| TORW-0101C-1 | 4 | In distribution | |
| G0804-32P02CN-1 | Length 4 in | 400 | In distribution |
| G0804-16P02C-1 | Length 4 in | 10 | In distribution |
| VPK-0272C-F | Width 2 in | In distribution | |
| VPK-0272C-R | Length 72 in | In distribution | |
| L1818-04P01CN-L | Length 18 in | 180 | In distribution |
| L1818-04P01CN-U | Width 18 in | 180 | In distribution |
| VPK-0448C-F | Width 4 in | In distribution | |
| G0404-32P01C-1 | Length 4 in | 10 | In distribution |
| PPK-023YC-R | Length,3,yard; | In distribution | |
| G0404-16P01CN-1 | Width 4 in | 1,400 | In distribution |
| L0409-04P01C-1 | Length 9 in | 5 | In distribution |
| G0303-12P01C-1 | Width 3 in | 10 | In distribution |
| TOR-0101C-1 | 4 | In distribution | |
| TST-0750C-1 | Outer Diameter.75 in | 5 | In distribution |
| L0418-04P01C-1 | Width 4 in | 5 | In distribution |
| L1818-04P02C-1 | Width 18 in | 10 | In distribution |
| L1818-04P01C-L | Width 18 in | 5 | In distribution |
| TORG-0101C-1 | 4 | In distribution | |
| TORG-0101CN-1 | 400 | In distribution | |
| G0404-16P01C-1 | Length 4 in | 10 | In distribution |
| L1836-04P01CN-1 | Length 36 in | 200 | In distribution |
| PPK-025YC-R | Length,5,yard; | In distribution | |
| TST-1000C-1 | Outer Diameter 1 in | 5 | In distribution |
| VPK-0496C-F | Length 96 in | In distribution | |
| L1818-04P01C-R | Length 18 in | 5 | In distribution |
| TST-1250C-1 | Outer Diameter 1.25 in | 5 | In distribution |
| L1818-04P02CN-1 | Width 18 in | 180 | In distribution |
| L1818-04P01CN-1 | Width 18 in | 180 | In distribution |
| G0804-12P02CN-1 | Width 8 in | 1,400 | In distribution |
| L0409-04P01CN-1 | Width 4 in | 1,120 | In distribution |
| TSD-1500C-1 | Outer Diameter 1.5 in | 5 | In distribution |
| TSD-1000C-1 | Outer Diameter 1 in | 5 | In distribution |
| G0804-24P02CN-1 | Length 4 in | 400 | In distribution |
| TSD-0875C-1 | Outer Diameter.875 in | 5 | In distribution |
| L1818-04P01CN-R | Length 18 in | 180 | In distribution |
| L0836-04P01C-1 | Width 8 in | 5 | In distribution |
| L0836-04P01CN-1 | Length 36 in | 400 | In distribution |
| VPK-0236C-R | Length 36 in | In distribution | |
| VPK-0436C-F | Length 36 in | In distribution | |
| TST-1500C-1 | Outer Diameter 1.5 in | 5 | In distribution |
| TST-0875C-1 | Outer Diameter.875 in | 5 | In distribution |
| G0202-08P01C-1 | Width 2 in | 10 | In distribution |
| G0404-32P01CN-1 | Length 4 in | 800 | In distribution |
| TSD-0750C-1 | Outer Diameter.75 in | 5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| AMD-Ritmed | AMD Medicom Inc. | 248 |
| DeRoyal | Deroyal Industries, Inc. | 172 |
| 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
3 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Covidien | UDI-DI | 2024-02-21 | Class II | Labeling mix-ups | Packs including 5 laparotomy sponges may contain incorrect product with a blue loop, X-ray detectable feature, and ethylene oxide treatment; however, this incorrect product wasn’t steam pre-treated prior to sterilization, and has no RF tag | 755,800 | |
| Covidien | UDI-DI | 2017-11-21 | Class II | Process control | Rechargeable lithium-ion batteries with incorrect firmware that are used in certain Puritan Bennett 980 ventilators may not fully charge after installation. | 15,885 | 2020-07-10 |
| Covidien | UDI-DI | 2017-10-12 | Class II | Nonconforming Material/Component | This voluntary recall is being conducted due to the potential for failure to detect the affected Situate” gauze – RF and Xray detectable products by the Situate” detection console due to a manufacturing error. | 20,800 | 2020-05-12 |
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.