Novo Surgical
zenith wartenberg neurological pin wheel, 7" (17.8 cm)
3manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (2), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Wenzhou Kangju Medical Instrument Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 15 |
| Ningbo Haishu Haoxin Medical Instrument Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 6 |
Record
| Listed by | Novo Surgical, Inc., United States |
|---|---|
| FDA product code | GWY |
| Device type | Pinwheel |
| Device class | Class 1 |
| Regulation | 21 CFR 882.1750 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2023-12-18 |
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 |
|---|---|---|
| G5541-36 | In distribution | |
| G95541-36 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Integra® Miltex® | Integra LifeSciences Production Corporation | 3 |
| McKesson | Mckesson Medical-Surgical Inc. | 2 |
| ADC® | American Diagnostic Corp. | 2 |
| BR Surgical, LLC | BR Surgical LLC | 1 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 1 |
| Grafco | GF Health Products, Inc | 1 |
| J&J Instruments | J & J Instruments, LLC | 1 |
| Orthomed | Ortho-MED, Inc. | 1 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 1 |
| gSource | Gsource, LLC. | 1 |
| Wartenberg PIN Wheel | Sontec Instruments, Inc. | 1 |
| V. Mueller | Steris Corporation | 1 |
Showing 12 of 13. All products under Pinwheel
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.