Elevator
Septum, Freer, Sharp/Blunt, 4.5/4.5 MM TIP
3manufacturers in China registered for this device type
35catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
Record
| Listed by | KLS-Martin L.P., United States |
|---|---|
| FDA product code | KAD |
| Device type | Elevator, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-06-12 |
| Record revised | 2024-08-26 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2021-04-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 39-100-17-07 | 17 CM | In distribution |
| 37-546-18-07 | 18.5 CM | In distribution |
| 36-739-17-07 | 18 CM | In distribution |
| 99-533-83-01 | 22 CM | In distribution |
| 39-023-18-07 | 18 CM | In distribution |
| 03-546-20-07 | 18 CM | In distribution |
| 36-036-21-07 | 15.5 CM | In distribution |
| 37-545-18-07 | 18 CM | In distribution |
| 39-021-18-07 | 18 CM | In distribution |
| 38-713-21-07 | 21 CM | In distribution |
| 99-594-07-01 | 22 CM | In distribution |
| 39-027-18-07 | 18 CM | In distribution |
| 36-737-20-07 | 20.5 CM | In distribution |
| 99-557-14-01 | In distribution | |
| 00-105-38-07 | 19 CM | In distribution |
| 37-547-20-07 | 21 CM | In distribution |
| 37-525-16-07 | 16 CM | In distribution |
| 36-036-23-07 | 16 CM | In distribution |
| 38-711-21-07 | 24 CM | In distribution |
| 37-521-04-07 | 15 CM | In distribution |
| 37-531-16-07 | 17 CM | In distribution |
| 37-497-19-07 | 18 CM | In distribution |
| 37-572-19-07 | 20 CM | In distribution |
| 37-560-18-07 | 18 CM | In distribution |
| 37-549-22-07 | 21.5 CM | In distribution |
| 37-521-05-07 | 15 CM | In distribution |
| 37-559-23-07 | 23 CM | In distribution |
| 37-566-21-07 | 20.5 CM | In distribution |
| 37-557-22-07 | 21.5 CM | Withdrawn |
| 38-020-02-07 | 16.5 CM | Withdrawn |
| 38-020-01-07 | 16.5 CM | Withdrawn |
| 38-020-04-07 | 16.5 CM | Withdrawn |
| 37-568-21-07 | 21 CM | Withdrawn |
| 37-562-22-07 | 23.5 CM | Withdrawn |
| 38-020-03-07 | 16.5 CM | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ambler Surgical | Ambler Surgical, LLC | 105 |
| MicroFrance® | Integra Microfrance SAS | 75 |
| Boss Instruments | Boss Instruments, Ltd. | 66 |
| V. Mueller | Steris Corporation | 60 |
| Novo Surgical | Novo Surgical, Inc. | 54 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 49 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 49 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 45 |
| Millennium | Avalign Technologies, Inc. | 43 |
| Pilling | Teleflex Medical LLC | 43 |
| Avalign | Avalign Technologies, Inc. | 41 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 35 |
Showing 12 of 111. All products under Elevator, Ent
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.