Fisturasper
The Fisturasper® is intended to be used for fistulas, independently formed, i.e., outwardly suppurating openings from the body through the skin, in order to remove the fistula lining to the…
The Fisturasper® is intended to be used for fistulas, independently formed, i.e., outwardly suppurating openings from the body through the skin, in order to remove the fistula lining to the outside by reaming.
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 | Qtec CE-MED Gmbh, Germany |
|---|---|
| FDA product code | GAC |
| Device type | Rasp, Surgical, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-07-17 |
| Record revised | 2025-04-04 (version 2) |
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, expiry date |
| Storage | Storage environment temperature 10 to 30 °C; Special storage condition: Keep dry, keep away from sunlight |
| Packaging | Carton of 10 |
| Distribution end date | 2023-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| S-XL | Size S-XL | In distribution |
| M+L | Size M+L | Withdrawn |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 |
| 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.