Integra®
Integra® Hajek-Kofler Sphenoid Punch, 6-3/4", Rotating
2manufacturers in China registered for this device type
10catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Anhui (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Anqing Changfan Medical Instrument Co., Ltd. | Anqing | Anhui | Manufacturer | 9 |
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | KAY |
| Device type | Punch, Nasal |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-17 |
| Record revised | 2025-01-17 (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, manufacturing date |
| Sizes | Width 2 to 4 mm; angle 70 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3712040 | In distribution | |
| 3712038 | In distribution | |
| 3712044 | In distribution | |
| 3712042 | In distribution | |
| 3712025 | 5-1/4″ | In distribution |
| 3712118 | Width 2 mm | In distribution |
| 3712039 | In distribution | |
| 3712119 | Width 3 mm | In distribution |
| 3712124 | 6-1/4″ | In distribution |
| 3712022 | 6-3/4″ | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 54 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 51 |
| AED | National Advanced Endoscopy Devices, Inc. | 30 |
| BR Surgical, LLC | BR Surgical LLC | 13 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 8 |
| Jedmed | Jedmed Instrument Company | 7 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 4 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 4 |
| MicroFrance® | Integra Microfrance SAS | 3 |
| Punch | KLS-Martin L.P. | 2 |
| Aesculap | Aesculap AG | 1 |
| Assi | Accurate Surgical & Scientific Instruments Corp. | 1 |
Showing 12 of 13. All products under Punch, Nasal
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.