71 MCE Custom
5 catalogue numbers from 71AR, listed by Sigvaris, Inc., United States, under Binder, Elastic. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
5catalogue numbers in this listing
Who Else Makes It
Concentrated in Fujian (1), Zhejiang (1), Henan (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xiamen J-Brace Medical Equipment Co., Ltd. | Xiamen | Fujian | Repacker / relabeller | 24 |
| Zhejiang Rehan Medical Manufacturing Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 20 |
| Linjiang (Holdings) Limited | Shangqiu | Henan | Private-label distributor | 11 |
Record
| Listed by | Sigvaris, Inc., United States |
|---|---|
| FDA product code | KMO |
| Device type | Binder, Elastic |
| Device class | Class 1 |
| Regulation | 21 CFR 880.5160 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-01-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 71AR | Pressure,15-20 mmHg | In distribution |
| 71TH | Pressure,15-20 mmHg | In distribution |
| 71LC | Pressure,15-20 mmHg | In distribution |
| 71LA | Pressure,15-20 mmHg | In distribution |
| 71BK | Pressure,15-20 mmHg | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medi | Medi Manufacturing Inc | 1,045 |
| 22 ChipPad | Sigvaris, Inc. | 67 |
| 26 ChipSleeve | Sigvaris, Inc. | 62 |
| 13 CompreShorts | Sigvaris, Inc. | 30 |
| 23 CompreShorts | Sigvaris, Inc. | 28 |
| 18 CompreBoot | Sigvaris, Inc. | 27 |
| 15 CompreSleeve | Sigvaris, Inc. | 15 |
| 18 Oversleeve Arm | Sigvaris, Inc. | 10 |
| 70 MCE Custom | Sigvaris, Inc. | 8 |
| 27 ChipSleeve | Sigvaris, Inc. | 2 |
| 72 MCE Custom | Sigvaris, Inc. | 2 |
| 73 MCE Custom | Sigvaris, Inc. | 2 |
Showing 12 of 42. All products under Binder, Elastic
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.