Stripper Scribe Tool
Catalogue number 11382, listed by Optical Integrity, Inc., United States, under Stripper, Surgical. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shanghai (3), Shandong (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
Record
| Listed by | Optical Integrity, Inc., United States |
|---|---|
| FDA product code | HRT |
| Device type | Stripper, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-04-11 |
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 | Handling environment temperature 10 to 37 °C |
| Sizes | Width 25 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11382 | Width 25 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dakota Alif System | Precision Spine, Inc. | 53 |
| Millennium | Avalign Technologies, Inc. | 32 |
| Ambler Surgical | Ambler Surgical, LLC | 30 |
| Instrument | Signus Medizintechnik Gmbh | 29 |
| Stripper | KLS-Martin L.P. | 25 |
| Buxton BioMedical | Buxton Biomedical, Inc. | 24 |
| Boss Instruments | Boss Instruments, Ltd. | 18 |
| Surtex | Surtex Instruments Ltd | 16 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 14 |
| Avalign | Avalign Technologies, Inc. | 12 |
| Stripper, Surgical | Biomet Microfixation | 12 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 11 |
Showing 12 of 62. All products under Stripper, Surgical
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.