Boss Instruments
Shambaugh Derlacki Needle, fine tip, 6 1/8"
3manufacturers in China registered for this device type
14catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (1), Jiangsu (1), Anhui (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Anhui Yixiang Trading Co., Ltd. | Hefei | Anhui | Repacker / relabeller | 13 |
Record
| Listed by | Boss Instruments, Ltd., United States |
|---|---|
| FDA product code | GDL |
| Device type | Needle, Suturing, Reusable |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-02-28 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 90-3411 | In distribution | |
| 90-3319 | In distribution | |
| 93-5590 | In distribution | |
| 90-3404 | In distribution | |
| 90-3205 | In distribution | |
| 90-3801 | In distribution | |
| 90-3320 | In distribution | |
| 90-3802 | In distribution | |
| 90-3403 | In distribution | |
| 90-3321 | In distribution | |
| 90-3322 | In distribution | |
| 90-3435 | In distribution | |
| 90-3711 | In distribution | |
| 93-5592 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Aesculap | Aesculap AG | 34 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 22 |
| Ambler Surgical | Ambler Surgical, LLC | 21 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 20 |
| Stoma® | Storz AM Mark Gmbh | 16 |
| Millennium | Avalign Technologies, Inc. | 14 |
| Novo Surgical | Novo Surgical, Inc. | 8 |
| Avalign | Avalign Technologies, Inc. | 6 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 5 |
| Jedmed | Jedmed Instrument Company | 3 |
| BR Surgical, LLC | BR Surgical LLC | 2 |
| V. Mueller | Carefusion 2200, Inc. | 2 |
Showing 12 of 23. All products under Needle, Suturing, Reusable
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.