Reflex
REFLEX ELC Endoscopic Clip Applier W/Titanium Clips, 10mm
6manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (3), Shanghai (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Hangzhou Endo Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Hangzhou Sunstone Technology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 1 |
Record
| Listed by | ConMed Corporation, United States |
|---|---|
| FDA product code | HBT |
| Device type | Applier, Hemostatic Clip |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K924929 |
| Record published | 2016-09-24 |
| Record revised | 2023-06-26 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 10 to 32 °C; Storage environment temperature 50 to 90 °F |
| Packaging | Carton of 6 |
| Sizes | Length 10 mm |
| Distribution end date | 2023-06-25 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 530 | Length 10 mm | 6 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vitalitec Clip Appliers | Vitalitec International, Inc. | 138 |
| Applier, hemostatic clip | Peters Surgical | 54 |
| Anastomosis Clip | Mizuho Corporation | 14 |
| GeniClip Open Applier | Genicon, Inc. | 6 |
| GeniClip Applier | Genicon, Inc. | 6 |
| Applier, Hemostatic Clip | S & T AG | 5 |
| Mica Appliers | Vitalitec International, Inc. | 5 |
| Europclip Applier | Ackermann Instrumente Gmbh | 5 |
| Aesculap | Aesculap AG | 5 |
| Ligaclip | Ethicon Endo-Surgery, Inc. | 3 |
| Applier, Hemostatic Clip | Black & Black Surgical, Inc. | 3 |
| Anastomosis Clip Applier | Mizuho Corporation | 2 |
Showing 12 of 14. All products under Applier, Hemostatic Clip
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.