Ambler Surgical
Kleinsasser laryngeal knife handle for use with 39-630, 39-631 and 39-632
2manufacturers in China registered for this device type
4catalogue 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 | Ambler Surgical, LLC, United States |
|---|---|
| FDA product code | JZY |
| Device type | Knife, Laryngeal |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2021-01-07 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Kleinsasser laryngeal knife | In distribution | |
| Kleinsasser laryngeal knife | In distribution | |
| Kleinsasser laryngeal knife | In distribution | |
| Kleinsasser laryngeal knife handle for use with 39-630 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MicroFrance® | Integra Microfrance SAS | 21 |
| Integra® | Integra LifeSciences Production Corporation | 11 |
| Jedmed | Jedmed Instrument Company | 7 |
| Knife, Laryngeal | Richard Wolf Gmbh | 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.