Medline Industries, Inc.
GUIDEWIRE.035X150 3MMJ Tcmc HB
10manufacturers in China registered for this device type
151catalogue numbers in this listing
Who Else Makes It
Concentrated in Beijing (4), Jiangsu (3), Guangdong (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Sunny Medical Device (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Lepu Medical Technology (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| Beijing Target Medical Technologies Inc. | Beijing | Beijing | Contract manufacturer | 7 |
| Suzhou Zenith Vascular Scitech Limited | Suzhou | Jiangsu | Manufacturer | 6 |
| Beijing Bywave Sensing Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
| Shanghai Achieva Medical Suzhou Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 2 |
| Deepintec Scientific Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | DQX |
| Device type | Wire, Guide, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1330 |
| 510(k) | K180177 |
| Record published | 2022-08-04 |
| Record revised | 2023-07-26 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 10, case of 5, case of 300, case of 100, case of 500, case of 450 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DNSC22609 | In distribution | |
| DYNJHWIRE117 | In distribution | |
| DYNJGWIRE12 | In distribution | |
| DNSC127760 | In distribution | |
| DNSC127946 | In distribution | |
| DYNJGWIRE06 | In distribution | |
| DNSC132766 | In distribution | |
| DYNJHWIRE109 | In distribution | |
| DNSC127751 | In distribution | |
| DYNJHWIRE131 | In distribution | |
| DNSC127757 | In distribution | |
| DYNJGWIRE53 | In distribution | |
| DYNJGWIRE33 | In distribution | |
| DYNJGWIRE51 | In distribution | |
| DNSC146695 | In distribution | |
| DYNJ44074A | In distribution | |
| DNSC88925 | In distribution | |
| DNSC129598 | In distribution | |
| DNSC107802 | In distribution | |
| DNSC126459 | In distribution | |
| DYNJGWIRE73 | In distribution | |
| DNSC88924 | In distribution | |
| DYNJGWIRE62 | In distribution | |
| DNSC88923 | In distribution | |
| DYNJGWIRE32 | In distribution | |
| DYNJHWIRE100 | In distribution | |
| DYNJHWIRE106 | In distribution | |
| DYNJGWIRE76 | In distribution | |
| DYNJGWIRE18 | In distribution | |
| DNSC31038 | In distribution | |
| DYNJHWIRE108 | In distribution | |
| DYNJHWIRE126 | In distribution | |
| DNSC127748 | In distribution | |
| DYNJGWIRE40 | In distribution | |
| DNSC32736 | In distribution | |
| DNSC29307A | In distribution | |
| DNSC145169 | In distribution | |
| DNSC127752 | In distribution | |
| DYNJZ88318 | In distribution | |
| DYNJGWIRE34 | In distribution | |
| DYNJHWIRE120 | In distribution | |
| DNSC102980 | In distribution | |
| DNSC129038 | In distribution | |
| DNSC127755 | In distribution | |
| DNSC17297 | In distribution | |
| DYNJHWIRE118 | In distribution | |
| DYNJHWIRE128 | In distribution | |
| DNSC133170 | In distribution | |
| DYNJHWIRE107 | In distribution | |
| DYNJGWIRE61 | In distribution | |
| DYNJHWIRE105 | In distribution | |
| DYNJGWIRE47 | In distribution | |
| DYNJGWIRE57 | In distribution | |
| DNSC135892 | In distribution | |
| DYNJHWIRE115 | In distribution | |
| DNSC127753 | In distribution | |
| DYNJGWIRE54 | In distribution | |
| DNSC94209 | In distribution | |
| DNSC125448 | In distribution | |
| DYNJGWIRE19 | In distribution | |
| DYNJHWIRE121 | In distribution | |
| DNSC127947 | In distribution | |
| DNSC22605 | In distribution | |
| DNSC119362 | In distribution | |
| DYNJGWIRE56 | In distribution | |
| DYNJGWIRE49 | In distribution | |
| DNSC29307 | In distribution | |
| DYNJGWIRE50 | In distribution | |
| DYNJHWIRE116 | In distribution | |
| DYNJHWIRE110 | In distribution | |
| DYNJGWIRE38 | In distribution | |
| DYNJGWIRE68 | In distribution | |
| DYNJGWIRE03 | In distribution | |
| DYNJHWIRE123 | In distribution | |
| DNSC88921 | In distribution | |
| DYNJGWIRE31 | In distribution | |
| DNSC22604 | In distribution | |
| DYNJGWIRE05 | In distribution | |
| DNSC127758 | In distribution | |
| DYNJGWIRE09 | In distribution | |
| DYNJGWIRE27 | In distribution | |
| DNSC94378 | In distribution | |
| DNSC22603 | In distribution | |
| DYNJGWIRE01 | In distribution | |
| DYNJHWIRE130 | In distribution | |
| DYNJGWIRE41 | In distribution | |
| DNSC127754 | In distribution | |
| DYNJGWIRE35 | In distribution | |
| DNSC127759 | In distribution | |
| DYNJHWIRE113 | In distribution | |
| DYNJHWIRE127 | In distribution | |
| DYNJGWIRE04 | In distribution | |
| DYNJGWIRE48 | In distribution | |
| DNSC131200 | In distribution | |
| DNSC127747 | In distribution | |
| DYNJGWIRE70 | In distribution | |
| DYNJGWIRE14 | In distribution | |
| DYNJGWIRE45 | In distribution | |
| DYNJHWIRE122 | In distribution | |
| DYNJGWIRE43 | In distribution | |
| DYNJHWIRE129 | In distribution | |
| DNSC94212 | In distribution | |
| DNSC127749 | In distribution | |
| DYNJGWIRE20L | In distribution | |
| DNSC49744 | In distribution | |
| DYNJGWIRE07 | In distribution | |
| DYNJGWIRE08 | In distribution | |
| DYNJGWIRE22 | In distribution | |
| DYNJGWIRE60 | In distribution | |
| DYNJGWIRE39 | In distribution | |
| DNSC138064 | In distribution | |
| DYNJGWIRE11 | In distribution | |
| DYNJGWIRE26 | In distribution | |
| DYNJGWIRE10 | In distribution | |
| DYNJHWIRE104 | In distribution | |
| DYNJHWIRE102 | In distribution | |
| DNSC125826 | In distribution | |
| DYNJGWIRE59 | In distribution | |
| DNSC13129 | In distribution | |
| DYNJHWIRE112 | In distribution | |
| DYNJHWIRE124 | In distribution | |
| DYNJGWIRE46 | In distribution | |
| DYNJGWIRE20 | In distribution | |
| DNSC125612 | In distribution | |
| DNSC13060A | In distribution | |
| DYNJHWIRE119 | In distribution | |
| DYNJHWIRE111 | In distribution | |
| DYNJHWIRE125 | In distribution | |
| DYNJGWIRE58 | In distribution | |
| DYNJGWIRE42 | In distribution | |
| DYNJGWIRE28 | In distribution | |
| DYNJGWIRE13 | In distribution | |
| DNSC146694 | In distribution | |
| VASC1241 | In distribution | |
| DNSC127746 | In distribution | |
| DYNJHWIRE103 | In distribution | |
| DYNJHWIRE101 | In distribution | |
| DYNJGWIRE52 | In distribution | |
| DYNJGWIRE69 | In distribution | |
| DYNJZ88920 | In distribution | |
| DYNJGWIRE30 | In distribution | |
| DYNJGWIRE44 | In distribution | |
| DYNJGWIRE67 | In distribution | |
| DYNJGWIRE29 | In distribution | |
| DNSC127750 | In distribution | |
| DYNJGWIRE36 | In distribution | |
| DYNJGWIRE71 | In distribution | |
| DYNJGWIRE16 | In distribution | |
| DYNJHWIRE114 | In distribution | |
| DNSC129573 | In distribution | |
| SAMPC0683 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 625 |
| Cook | Cook Incorporated | 410 |
| Guidewire | Argon Medical Devices, Inc. | 173 |
| Guidewire | Galt Medical Corp. | 144 |
| Amplatz | Cook Incorporated | 128 |
| InQwire® | Merit Medical Systems, Inc. | 120 |
| Angiographic Guide Wire | Medtronic, Inc. | 94 |
| Glidewire | Terumo Corp. | 83 |
| Starter™ Guidewire | Lake Region Medical Limited | 82 |
| INT,Falcon Guide Wire | Shanghai Kindly Medical Instruments Co., Ltd. | 72 |
| GuideRight™ | St. Jude Medical | 69 |
| INT, FirstWire | Shanghai Kindly Medical Instruments Co., Ltd. | 65 |
Showing 12 of 525. All products under Wire, Guide, Catheter
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2026-02-25 | Class II | No Marketing Application | The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. | 74,085 units |
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.