Snowden-Pencer
Snowden-Pencer Plastics DIAMOND-TIP RASPS WEBSTER GLABELLA 20,7CM 8 1/8 inches, COARSE
6manufacturers in China registered for this device type
20catalogue 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 | Steris 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, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-07-12 |
| Record revised | 2024-08-12 (version 5) |
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 |
| Distribution end date | 2024-11-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 32-3026 | In distribution | |
| 32-3012 | In distribution | |
| 32-3105 | In distribution | |
| 32-3016 | In distribution | |
| 32-3018 | In distribution | |
| 88-3200 | In distribution | |
| 32-3002 | In distribution | |
| 32-3102 | In distribution | |
| 32-3120 | In distribution | |
| 32-3011 | In distribution | |
| 32-3115 | In distribution | |
| 32-3101 | In distribution | |
| 32-3015 | In distribution | |
| 88-3201 | In distribution | |
| 32-3004 | In distribution | |
| 32-3008 | In distribution | |
| 32-3017 | In distribution | |
| 32-3013 | In distribution | |
| 32-3006 | In distribution | |
| 32-3014 | Withdrawn |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.