Sense Mirror
Urinary catheter positioning mirror
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
All of them in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Ningyuan Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 80 |
| Ningbo Castle Medical Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 67 |
Record
| Listed by | Wellspect Healthcare, Sweden |
|---|---|
| FDA product code | FTX |
| Device type | Mirror, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-12-13 |
| Record revised | 2023-04-04 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date |
| Storage | Special storage condition: Store in a dry place at room temperature. |
| Sizes | Width 70 mm; length 125 mm |
| Distribution end date | 2022-04-11 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3895 | Width 70 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Power Dental USA | Power Dental U.S.A. Inc. | 36 |
| Power Dental U.S.A., Inc. | Power Dental U.S.A. Inc. | 8 |
| Lazic | Peter Lazic Gmbh | 4 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 3 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 2 |
| Symmetry House | Aspen Surgical Products, Inc. | 1 |
| Millennium | Avalign Technologies, Inc. | 1 |
| Ambler Surgical | Ambler Surgical, LLC | 1 |
| Teaching Mirror | Sontec Instruments, Inc. | 1 |
| Avalign | Avalign Technologies, Inc. | 1 |
| Garg | Power Dental U.S.A. Inc. | 1 |
| Aesculap | Aesculap AG | 1 |
Showing 12 of 14. All products under Mirror, General & Plastic Surgery
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.