Kmedic
Polokoff Rasp, 8 1/2"DOUBLE Ended 6 Millimeter
6manufacturers in China registered for this device type
17catalogue 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 | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | GAC |
| Device type | Rasp, Surgical, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-15 |
| Record revised | 2022-06-10 (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, manufacturing date |
| Sizes | Length 15.2 to 30.5 cm; length 8.25 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN015419 | Length 19 cm | In distribution |
| IPN015415 | Length 21 cm | In distribution |
| IPN015673 | Double ended Plain serrations | In distribution |
| IPN015440 | Single ended | In distribution |
| IPN013953 | Double ended Fine and coarse serrations | In distribution |
| IPN015671 | Double ended Plain serrations | In distribution |
| IPN013950 | Length 30.5 cm | In distribution |
| IPN015413 | Single ended Backward cutting | In distribution |
| IPN015438 | Length 15.2 cm | In distribution |
| IPN015679 | Length 21.6 cm | In distribution |
| IPN013952 | Length 26.7 cm | In distribution |
| IPN015437 | Length 15.2 cm | In distribution |
| IPN013985 | Length 27.9 cm | In distribution |
| IPN013948 | Length 24.1 cm | In distribution |
| IPN015420 | Length 19 cm | In distribution |
| IPN013951 | Double ended Fine and course serrations | In distribution |
| IPN015672 | Length 20 cm | 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 |
| Hayden Medical | Hayden Medical Inc | 36 |
| Sklar | Sklar Corporation | 33 |
| Medline | Medline Industries, Inc. | 32 |
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.