Integra®
Integra® House Strut Caliper, 6-1/2", Malleable, Marker 4.5mm From Tip
1manufacturer
4catalogue numbers in this listing
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | JYZ |
| Device type | Rod, Measuring Ear |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-10-24 |
| Record revised | 2023-04-17 (version 4) |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3722078 | Marker 4mm From Tip | In distribution |
| 3722079 | 6-1/2″ | In distribution |
| 3722077 | Marker 3.5mm From Tip | In distribution |
| 3722080 | Marker 5mm From Tip | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MicroFrance® | Integra Microfrance SAS | 22 |
| V. Mueller | Steris Corporation | 6 |
| Avalign | Avalign Technologies, Inc. | 4 |
| Bear | Mytamed, Inc. | 4 |
| Ambler Surgical | Ambler Surgical, LLC | 4 |
| Symmetry House | Aspen Surgical Products, Inc. | 4 |
| Pilling | Teleflex Medical LLC | 4 |
| ROD | KLS-Martin L.P. | 4 |
| Aesculap | Aesculap AG | 4 |
| Caversaccio Tympano Sizer | Spiggle & Theis Medizintechnik Gmbh | 3 |
| Millennium | Avalign Technologies, Inc. | 3 |
| Bear | Bear-ENT, LLC | 2 |
Showing 12 of 16. All products under Rod, Measuring Ear
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.