Intrace USA
Politzer Myringotome (Myringotomy Knife), 16 cm (approx. 6.3") Overall Length, Sharp Lance-Shaped Tip, Stainless Steel Handle, Reusable.
1manufacturer
1catalogue number
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
Record
| Listed by | Pilotis Tech LLC, United States |
|---|---|
| FDA product code | JYP |
| Device type | Knife, Myringotomy |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-07-03 |
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 | Length 16 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 12-228-160 | Length 16 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Exmoor | Exmoor Plastics Limited | 116 |
| Integra® | Integra LifeSciences Production Corporation | 6 |
| BR Surgical, LLC | BR Surgical LLC | 2 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 2 |
| Novo Surgical | Novo Surgical, Inc. | 2 |
| Adept Medical | Jedmed Instrument Company | 2 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 2 |
| MicroFrance® | Integra Microfrance SAS | 2 |
| Jedmed | Jedmed Instrument Company | 1 |
| Adept Medical Myringotomy Knife | Adept Medical Ltd | 1 |
| Aesculap | Aesculap AG | 1 |
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.