YES Tape
Catalogue number 1113-00, listed by Lemaitre Vascular, Inc., United States, under Assembly, Thigh/Knee/Shank/Ankle/Foot, External. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
2recalls on this code
Who Else Makes It
All of them in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Meiguan Care Products Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 32 |
| Changzhou Major Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 31 |
| Yangzhou Sensport Healthcare Supplies Co., Ltd. | Yangzhou | Jiangsu | Manufacturer | 27 |
Record
| Listed by | Lemaitre Vascular, Inc., United States |
|---|---|
| FDA product code | KFX |
| Device type | Assembly, Thigh/Knee/Shank/Ankle/Foot, External |
| Device class | Class 2 |
| Regulation | 21 CFR 890.3500 |
| Establishment | Manufacturer |
| Record published | 2021-06-18 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1113-00 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| VascuTape Radiopaque Tape | Lemaitre Vascular, Inc. | 9 |
| Vesper Custom Tape | Lemaitre Vascular, Inc. | 1 |
| Mirabrush Blue Straight | Hager Worldwide, Inc. | 1 |
| Mirabrush Yellow Pointed | Hager Worldwide, Inc. | 1 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-03-18 | Class II | Packaging process control | Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised. | 6970 | 2014-12-03 |
| 2013-03-18 | Class II | Packaging process control | Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised. | 13560 | 2014-12-03 |
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.