ADx
Guidewire, Ptfe 035 X 150CM FC 3MM J Newton LT
10manufacturers in China registered for this device type
62catalogue 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 | AngioDynamics, Inc., United States |
|---|---|
| FDA product code | DQX |
| Device type | Wire, Guide, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1330 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2021-01-07 |
| Record revised | 2024-11-12 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 10 |
| Sizes | Outer diameter 0.018 to 0.038 in; length 60 to 260 cm |
| Distribution end date | 2024-11-11 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 815435150 | Outer Diameter 0.035 in | In distribution |
| 910538180 | Length 180 cm | In distribution |
| 816638180 | Length 180 cm | In distribution |
| 810638180 | .038″ x 180cm x 1.5mm J | In distribution |
| 815438150 | Length 150 cm | In distribution |
| 815332060 | .032″ x 60cm | In distribution |
| 810638260 | Outer Diameter 0.038 in | In distribution |
| 815238150 | Length 150 cm | In distribution |
| 911535150 | Outer Diameter 0.035 in | In distribution |
| 814138080 | .038″ x 80cm | In distribution |
| 810125150 | Outer Diameter 0.025 in | In distribution |
| 810638150 | .038″ x 150cm x 1.5mm J | In distribution |
| 810735150 | Outer Diameter 0.035 in | In distribution |
| 810635150 | .035″ x 150cm x 1.5mm J | In distribution |
| 910538150 | Outer Diameter 0.038 in | In distribution |
| 814138150 | Outer Diameter 0.038 in | In distribution |
| 815318060 | Length 60 cm | In distribution |
| 816638260 | Outer Diameter 0.038 in | In distribution |
| 815338150 | Outer Diameter 0.038 in | In distribution |
| 910532150 | Outer Diameter 0.032 in | In distribution |
| 810538080 | .038″ x 80cm x 3mm J | In distribution |
| 810132150 | Outer Diameter 0.021 in | In distribution |
| 810532260 | Length 260 cm | In distribution |
| 814138260 | Length 260 cm | In distribution |
| 816635080 | .035″ x 80cm x 1.5mm J | In distribution |
| 810938150 | Length 150 cm | In distribution |
| 815325060 | Outer Diameter 0.025 in | In distribution |
| 810635080 | Outer Diameter 0.035 in | In distribution |
| 816638080 | Length 80 cm | In distribution |
| 815538150 | Outer Diameter 0.038 in | In distribution |
| 810118150 | Length 150 cm | In distribution |
| 810635260 | Outer Diameter 0.035 in | Withdrawn |
| 816635180 | Outer Diameter 0.035 in | Withdrawn |
| 815535150 | Length 150 cm | Withdrawn |
| 810535150 | .035″ x 150cm x 3mmJ | Withdrawn |
| 810138260 | Length 260 cm | Withdrawn |
| 814135150 | Outer Diameter 0.035 in | Withdrawn |
| 810835150 | Length 150 cm | Withdrawn |
| 8109351501 | Length 150 cm | Withdrawn |
| 910535150 | .035″ x 150cm x 3MM J | Withdrawn |
| 810935150 | Outer Diameter 0.035 in | Withdrawn |
| 810525150 | Outer Diameter 0.035 in | Withdrawn |
| 810532150 | .032″ x 150cm x 3mm J | Withdrawn |
| 810538180 | Outer Diameter 0.038 in | Withdrawn |
| 810135260 | Outer Diameter 0.035 in | Withdrawn |
| 810535180 | .035″ x 180cm x 3mmJ | Withdrawn |
| 810525260 | .021″ x 150cm x 3mm J | Withdrawn |
| 816635150 | Outer Diameter 0.035 in | Withdrawn |
| 816635260 | Length 260 cm | Withdrawn |
| 810538150 | Length 150 cm | Withdrawn |
| 815235150 | Outer Diameter 0.035 in | Withdrawn |
| 810538260 | Length 260 cm | Withdrawn |
| 810535080 | Length 80 cm | Withdrawn |
| 814135260 | Length 260 cm | Withdrawn |
| 814135180 | Length 180 cm | Withdrawn |
| 910638150 | Outer Diameter 0.038 in | Withdrawn |
| 810535260 | Length 260 cm | Withdrawn |
| 814135080 | Outer Diameter 0.035 in | Withdrawn |
| 815335150 | .035″ x 150cm | Withdrawn |
| 810138150 | Length 150 cm | Withdrawn |
| 910635150 | Length 150 cm | Withdrawn |
| 810135150 | Outer Diameter 0.035 in | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 625 |
| Cook | Cook Incorporated | 410 |
| Guidewire | Argon Medical Devices, Inc. | 173 |
| Medline Industries, Inc. | Medline Industries, Inc. | 151 |
| 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 |
Showing 12 of 525. All products under Wire, Guide, Catheter
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.