Integra® Miltex®
Integra® Miltex® Fomon Rasp, 8-1/4", Double-Ended, Convex and Flat Sides, Fine and Coarse, Backward Cutting
6manufacturers in China registered for this device type
46catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (2), Shandong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | GAC |
| Device type | Rasp, Surgical, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-01-10 |
| Record revised | 2024-05-14 (version 7) |
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 |
| Sizes | Length 7 to 8 in; width 7.6 to 8.7 mm; length 40 mm |
| Distribution end date | 2023-12-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 21-381TC | In distribution | |
| PM-4881 | In distribution | |
| 21-383TC | In distribution | |
| 21-352 | In distribution | |
| MH21-330 | In distribution | |
| MH21-348 | In distribution | |
| 21-343 | 8-1/4″ | In distribution |
| 21-354 | 16mm x 7mm Blade | In distribution |
| 21-388TC | In distribution | |
| 21-348 | In distribution | |
| PM-4878 | Width 8.7 mm | In distribution |
| 21-368 | In distribution | |
| PM-4880 | In distribution | |
| 21-369 | In distribution | |
| 21-384TC | In distribution | |
| MH21-369 | In distribution | |
| MH21-370 | 8-1/2″ | In distribution |
| 21-382TC | In distribution | |
| 21-370 | In distribution | |
| PM-7411 | In distribution | |
| 21-346 | In distribution | |
| 21-338 | Width 7.6 mm | In distribution |
| 21-330 | In distribution | |
| MH21-338 | In distribution | |
| MH21-346 | In distribution | |
| MH21-342 | In distribution | |
| MH21-368 | In distribution | |
| PM-1448 | Length 7 in | In distribution |
| PM-2105 | In distribution | |
| PM-7422 | In distribution | |
| 21-386TC | In distribution | |
| 21-392DC | In distribution | |
| 21-342 | Length 7 in | In distribution |
| 21-360 | In distribution | |
| PM-550 | In distribution | |
| 21-385TC | In distribution | |
| 21-387TC | In distribution | |
| 21-393DC | In distribution | |
| 21-389TC | In distribution | |
| 21-380TC | In distribution | |
| 21-394TC | In distribution | |
| PM-4877 | In distribution | |
| 21-390TC | Withdrawn | |
| PM-2034 | Withdrawn | |
| PM-2035 | Withdrawn | |
| PM-2031 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rasp, Surgical, General & Plastic Surgery | Depuy Spine, Inc. | 102 |
| American Medicals | American Medicals | 95 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 55 |
| Rasp, Surgical, General & Plastic Surgery | Wright Medical Technology, Inc. | 50 |
| Surtex | Surtex Instruments Ltd | 47 |
| Aesculap | Aesculap AG | 45 |
| Ambler Surgical | Ambler Surgical, LLC | 39 |
| Innomed, Inc. | Innomed, Inc. | 39 |
| Hayden Medical | Hayden Medical Inc | 36 |
| Sklar | Sklar Corporation | 33 |
| Medline | Medline Industries, Inc. | 32 |
| Millennium | Avalign Technologies, Inc. | 31 |
Showing 12 of 123. All products under Rasp, Surgical, General & Plastic Surgery
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.