Hayden Medical
Aufricht Glabella Rasp 8-1/4" (20.6cm), head curved backward, teeth set for up and down cutting
6manufacturers in China registered for this device type
36catalogue 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 | Hayden Medical Inc, United States |
|---|---|
| FDA product code | GAC |
| Device type | Rasp, Surgical, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2022-07-27 |
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 |
|---|---|---|
| 210-364 | In distribution | |
| 210-429 | In distribution | |
| 210-354 | In distribution | |
| 210-343 | In distribution | |
| 210-428 | In distribution | |
| 210-342 | In distribution | |
| 210-365 | In distribution | |
| 210-339 | In distribution | |
| 210-372 | In distribution | |
| 210-361 | In distribution | |
| 210-360 | In distribution | |
| 210-399 | In distribution | |
| 210-362 | In distribution | |
| 210-369F | In distribution | |
| 210-366 | In distribution | |
| 210-342TC | In distribution | |
| 210-363 | In distribution | |
| 210-346 | In distribution | |
| 210-330 | In distribution | |
| 210-368 | In distribution | |
| 210-380 | In distribution | |
| 210-329 | In distribution | |
| 210-370 | In distribution | |
| 210-374 | In distribution | |
| 210-398 | In distribution | |
| 210-352 | In distribution | |
| 210-349 | In distribution | |
| 210-341TC | In distribution | |
| 210-338 | In distribution | |
| 210-341 | In distribution | |
| 210-371 | In distribution | |
| 210-344TC | In distribution | |
| 210-348 | In distribution | |
| 210-340 | In distribution | |
| 210-367 | In distribution | |
| 210-369 | In distribution |
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 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 46 |
| Aesculap | Aesculap AG | 45 |
| Ambler Surgical | Ambler Surgical, LLC | 39 |
| Innomed, Inc. | Innomed, Inc. | 39 |
| 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.