Medline
ZR-081 LG Strgt CUT Rasp 12.5MM X 6.5MM
6manufacturers in China registered for this device type
32catalogue 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 | Medline Industries, Inc., United States |
|---|---|
| FDA product code | GAC |
| Device type | Rasp, Surgical, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Premarket notification | Exempt |
| Record published | 2022-05-18 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Packaging | Case of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ZR081RH | In distribution | |
| SR086RH | In distribution | |
| SR51082RH | In distribution | |
| SR51081RH | In distribution | |
| KM5100371RH | In distribution | |
| KM80RH | In distribution | |
| 5053082R | In distribution | |
| 5053080RH | In distribution | |
| 510037125RH | In distribution | |
| KM800RH | In distribution | |
| 1675116RH | In distribution | |
| KM5100373RH | In distribution | |
| KM5100374RH | In distribution | |
| KM82RH | In distribution | |
| KM81RH | In distribution | |
| 5053083R | In distribution | |
| KM5100372RH | In distribution | |
| SR082RH | In distribution | |
| ZR083RH | In distribution | |
| SR51083RH | In distribution | |
| 510037126RH | In distribution | |
| KM802RH | In distribution | |
| 510037119RH | In distribution | |
| 51108030RH | In distribution | |
| ZR082RH | In distribution | |
| 510037115RH | In distribution | |
| 510037114RH | In distribution | |
| SR51080RH | In distribution | |
| 510037116RH | In distribution | |
| 1675114RH | In distribution | |
| ZR080RH | In distribution | |
| 510037127RH | 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 |
| 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.