ProdiGI
Secondary Grasper
1manufacturer
5catalogue numbers in this listing
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
Record
| Listed by | Covidien LP, United States |
|---|---|
| FDA product code | QSW |
| Device type | Endoscopic Traction Device |
| Device class | Class 2 |
| Regulation | 21 CFR 876.4410 |
| 510(k) | DEN220006 |
| Record published | 2022-07-15 |
| Record revised | 2026-01-12 (version 14) |
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 |
| Storage | Storage environment temperature up to 22 °C; Special storage condition: Keep dry |
| Packaging | Case of 2 |
| Sizes | Length 9.5 to 35 mm |
| Distribution end date | 2026-01-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ERD-TMLG | Length 17 mm | Withdrawn |
| ERD-TWSG | Withdrawn | |
| ERD-TW35 | Length 35 mm | Withdrawn |
| ERD-TW20 | Length 20 mm | Withdrawn |
| ERD-TMST | Length 9.5 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SureTrac(TM) Elastic Traction System | Micro-Tech (Nanjing) Co., Ltd. | 14 |
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.