Integra® Miltex®
Integra® Miltex® Packer and Excavator 5-5/8", Double-Ended, 2mm x 22mm Packer and Blunt Hook End
5manufacturers in China registered for this device type
59catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Shandong (1), Hubei (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 |
| Hubei Lanbin Medical Group Co., Ltd. | Xiaogan | Hubei | Contract manufacturer | 33 |
| Guilin Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | EKC |
| Device type | Excavator, Dental, Operative |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-04-19 |
| Record revised | 2023-04-27 (version 6) |
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 | 2023-12-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 40-90 | In distribution | |
| 70-20 | In distribution | |
| 70-18 | In distribution | |
| 70-8 | In distribution | |
| 70-12 | In distribution | |
| 70-22 | In distribution | |
| 70-2 | In distribution | |
| 70-6 | In distribution | |
| 70-4 | In distribution | |
| 70-16 | In distribution | |
| 70-14 | In distribution | |
| 70-10 | In distribution | |
| THES15 | Withdrawn | |
| THE32L | Withdrawn | |
| 017-28033 | Withdrawn | |
| THE115-UU | Withdrawn | |
| 80-6304 | Withdrawn | |
| THE33L | Withdrawn | |
| THES11 | Withdrawn | |
| THEE2 | Withdrawn | |
| THE15-KG | Withdrawn | |
| THES1 | Withdrawn | |
| 80-6303 | Withdrawn | |
| 80-6302 | Withdrawn | |
| THES2 | Withdrawn | |
| THE2 | Withdrawn | |
| THE2RY | Withdrawn | |
| THE31WBLB | Withdrawn | |
| THE1 | Withdrawn | |
| THEE3 | Withdrawn | |
| THE17 | Withdrawn | |
| THE18 | Withdrawn | |
| THE20 | Withdrawn | |
| 017-28032 | Withdrawn | |
| THE31WBL | Withdrawn | |
| THE115 | Withdrawn | |
| THES15LL | Withdrawn | |
| THEE1 | Withdrawn | |
| THE31WGG | Withdrawn | |
| THES15-GW | Withdrawn | |
| 80-6307 | Withdrawn | |
| 017-28001 | Withdrawn | |
| THE15 | Withdrawn | |
| 80-6300 | Withdrawn | |
| THE19 | Withdrawn | |
| THE31L-KB | Withdrawn | |
| 80-6306 | Withdrawn | |
| THES4243 | Withdrawn | |
| THE115BKG | Withdrawn | |
| THES4243KK | Withdrawn | |
| THE15KG | Withdrawn | |
| THE115B-KK | Withdrawn | |
| THE31L | Withdrawn | |
| THE115RD | Withdrawn | |
| THE15X-UU | Withdrawn | |
| THW15X-KG | Withdrawn | |
| THE31W | Withdrawn | |
| THE6061 | Withdrawn | |
| THE15X-DN | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HU-Friedy | HU-Friedy MFG Co., LLC | 193 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 149 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 44 |
| A. Titan Instruments | A. Titan Instruments, Inc. | 43 |
| Excavator Double Ended | Maillefer Instruments Holding Sàrl | 36 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 35 |
| Power Dental USA | Power Dental U.S.A. Inc. | 34 |
| Premier Excavators | Premier Dental Products Co. | 30 |
| Zoll-Dental | Zoll-Dental | 28 |
| Kohdent | Kohler Medizintechnik GmbH | 27 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 27 |
| Osung MND | Osung MND Co., Ltd. | 24 |
Showing 12 of 52. All products under Excavator, Dental, Operative
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.