Integra® Miltex®
Integra® Miltex® Wartenberg Pin Wheel, 7-3/4"
3manufacturers in China registered for this device type
3catalogue 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 | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | GWY |
| Device type | Pinwheel |
| Device class | Class 1 |
| Regulation | 21 CFR 882.1750 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-01-22 |
| Record revised | 2023-05-02 (version 4) |
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 |
|---|---|---|
| V91-226 | In distribution | |
| 1-226 | In distribution | |
| MH1-226 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| McKesson | Mckesson Medical-Surgical Inc. | 2 |
| Novo Surgical | Novo 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.