Knife
EAR, Politzer, Angled
2manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), 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 |
Record
| Listed by | KLS-Martin L.P., United States |
|---|---|
| FDA product code | JYO |
| Device type | Knife, Ear |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-26 |
| Record revised | 2025-01-27 (version 7) |
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 | 2025-01-25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 36-657-16-07 | 16 CM | Withdrawn |
| 36-619-15-07 | 15 CM | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bausch + Lomb | Bausch & Lomb Incorporated | 52 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 48 |
| MicroFrance® | Integra Microfrance SAS | 43 |
| V. Mueller | Steris Corporation | 36 |
| Integra® | Integra LifeSciences Production Corporation | 32 |
| Jedmed | Jedmed Instrument Company | 30 |
| HNM Medical | HNM Stainless, LLC. | 29 |
| Inka | The Trustee for Kaiser Family Trust | 23 |
| Ambler Surgical | Ambler Surgical, LLC | 22 |
| Aesculap | Aesculap AG | 21 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 18 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 15 |
Showing 12 of 41. All products under Knife, 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.