Integra®
Integra® Blitzer Disposable Laryngeal Knife,Circular Tip
2manufacturers in China registered for this device type
11catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Guangzhou Nuoning Medical Supplies Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 62 |
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | JZY |
| Device type | Knife, Laryngeal |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-04-16 |
| Record revised | 2025-07-02 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Width 20 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| MCL-S32 | 6 | In distribution | |
| MCL-S33 | 6 | In distribution | |
| 3734114 | 4-1/2″ | In distribution | |
| 3734123 | 11-1/2″ | In distribution | |
| 1422100 | 5 | In distribution | |
| 1422400 | In distribution | ||
| 9622400 | In distribution | ||
| 3734124 | 12-1/4″ | In distribution | |
| 1422300 | 5 | In distribution | |
| 3734117 | 9-3/4″ | In distribution | |
| 1422200 | 5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MicroFrance® | Integra Microfrance SAS | 21 |
| Jedmed | Jedmed Instrument Company | 7 |
| Knife, Laryngeal | Richard Wolf Gmbh | 4 |
| Ambler Surgical | Ambler Surgical, LLC | 4 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 4 |
| Avalign | Avalign Technologies, Inc. | 3 |
| Integra® MicroFrance® | Integra LifeSciences Production Corporation | 2 |
| Aesculap | Aesculap AG | 2 |
| Millennium | Avalign Technologies, Inc. | 1 |
| V. Mueller | Steris Corporation | 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.