Integra® Miltex®
Integra® Miltex® Ballenger-Hajek Septum Elevator, 7-1/2", Double-Ended, Semi-Sharp and Blunt Blades
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 | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | KAD |
| Device type | Elevator, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-02-26 |
| Record revised | 2024-03-06 (version 9) |
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 |
| Sizes | Width 1 to 9 mm; length 7 to 8 in; angle 15 °; length 12 mm |
| Distribution end date | 2022-05-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 62-182 | In distribution | |
| 19-1330 | In distribution | |
| 21-61 | In distribution | |
| 22-302 | 7-3/4″ | In distribution |
| PM-4425 | In distribution | |
| 20-246 | 8-1/4″ | In distribution |
| 20-240 | Length 7 in | In distribution |
| 62-180 | In distribution | |
| PM-4434 | In distribution | |
| 20-238 | Length 7 in | In distribution |
| PM-4441 | 8-3/4″ | In distribution |
| PM-602 | 7-1/4″ | In distribution |
| 62-183 | In distribution | |
| 19-1340 | In distribution | |
| 19-1334 | In distribution | |
| 21-65 | 6.5mm Wide | In distribution |
| 62-185 | In distribution | |
| PM-4429 | Width 6.5 mm | In distribution |
| PM-4435 | In distribution | |
| MH20-258 | 7-1/2″ | In distribution |
| 22-300 | 7-1/2″ | In distribution |
| PM-4440 | In distribution | |
| 20-258 | 7-1/2″ | In distribution |
| 19-2518 | Angle 15 ° | In distribution |
| 19-1336 | In distribution | |
| 22-304 | In distribution | |
| 62-181 | In distribution | |
| PM-600 | 7-1/4″ | In distribution |
| 20-230 | 8-1/2″ | In distribution |
| 19-2520 | In distribution | |
| PM-4431 | Width 9 mm | In distribution |
| 19-1341 | In distribution | |
| 62-184 | In distribution | |
| 20-242 | Length 8 in | In distribution |
| MH20-246 | 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 |
| Elevator | KLS-Martin L.P. | 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.