HI-Line
HI-Line Diamond Burr II EXCEPT.LG.D4.5MM
3manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (1), Jiangsu (1), Hong Kong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Changzhou 3R Medical Device Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 16 |
| Svenson Network Holdings Limited | Hk | Hong Kong | Manufacturer | 7 |
Record
| Listed by | Aesculap AG, Germany |
|---|---|
| FDA product code | GEF |
| Device type | Applier, Staple, Surgical, |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-04-23 |
| Record revised | 2022-01-28 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2021-04-30 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GD711R | In distribution | |
| GD710R | Withdrawn | |
| GD701R | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Applier, Staple, Surgical, | DePuy Mitek, Inc. | 4 |
| GII | DePuy Mitek, Inc. | 2 |
| Rigidfix | Medos International Sàrl | 1 |
| Applier, Staple, Surgical, | Zimmer, Inc. | 1 |
| Tacit | DePuy Mitek, Inc. | 1 |
| Intrafix | DePuy Mitek, Inc. | 1 |
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.