V. Mueller
Smillie Knife Curved Right Overall Length 6-3/4" (17.1CM)
2manufacturers in China registered for this device type
3catalogue 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 | Carefusion 2200, Inc., United States |
|---|---|
| FDA product code | GDN |
| Device type | Knife, Amputation |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-10 |
| Record revised | 2019-12-11 (version 2) |
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 | 2019-01-23 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OS5212-003 | Withdrawn | |
| OS5212-001 | Withdrawn | |
| OS5212-002 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| American Medicals | American Medicals | 9 |
| Aesculap | Aesculap AG | 8 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 7 |
| Sklar® | Sklar Corporation | 6 |
| Ambler Surgical | Ambler Surgical, LLC | 4 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 2 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 2 |
| gSource | Gsource, LLC. | 2 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 2 |
| V. Mueller | Steris Corporation | 2 |
| HNM Medical | HNM Stainless, LLC. | 2 |
| Avalign | Avalign Technologies, Inc. | 2 |
Showing 12 of 21. All products under Knife, Amputation
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.