Swann Morton Ltd.
A sterile, hand held, manual surgical instrument constructed as a one piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue.…
A sterile, hand held, manual surgical instrument constructed as a one piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single use device.
14manufacturers in China registered for this device type
165catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (6), Zhejiang (3), Guangdong (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Nanjing J SUN Healthcare Co., Ltd. | Nanjing | Jiangsu | Repacker / relabeller | 56 |
| Shanghai Hua En Industrial Co Ltd | Shanghai | Shanghai | Contract manufacturer | 52 |
| Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | Weihai | Shandong | Contract manufacturer | 37 |
| Guangdong Comfort Medical Products Co., Ltd. | Jiangmen | Guangdong | Repacker / relabeller | 28 |
| Anhui Yixiang Trading Co., Ltd. | Hefei | Anhui | Repacker / relabeller | 13 |
| Huaian Angel Medical Instrument Co., Ltd. | Huaian | Jiangsu | Manufacturer | 11 |
Showing 12 of 14. All 14 manufacturers in China registered for Scalpel, One-Piece
Record
| Listed by | Swann Morton, Ltd., United Kingdom |
|---|---|
| FDA product code | GDX |
| Device type | Scalpel, One-Piece |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-05-30 |
| Record revised | 2024-04-18 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2024-04-17 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| PARAGON No. 11 STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| BOX 100 No.10 NON STERILE MINOR DISPOSABLE SCALPELS | 100 | In distribution | |
| LANCE No. 11 NON STERILE DISPOSABLE SCALPELS | 100 | In distribution | |
| PARAGON No. 20 STERILE DISPOSABLE SCALPEL WITH RETRACTING GUARD | 10 | In distribution | |
| No.12 STERILE RETRACTABLE SCALPELS | 25 | In distribution | |
| No.15 BULK NON STERILE DISPOSABLE SCALPELS WITH GUARD | 1,000 | In distribution | |
| No.10R STERILE RETRACTABLE SCALPELS | 25 | In distribution | |
| LANCE No. 15 STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| No. 10 NON STERILE MINOR DISPOSABLE SCALPELS | 10 | In distribution | |
| No. 23 BULK NON STERILE DISPOSABLE SCALPELS WITH GUARD | 1,000 | In distribution | |
| No. 26 BULK NON STERILE DISPOSABLE SCALPELS WITH GUARD | 1,000 | In distribution | |
| PARAGON No. 21 STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| No. 10R STERILE DISPOSABLE SCALPELS WITH GUARD | 10 | In distribution | |
| No. 10 BULK NON STERILE DISPOSABLE SCALPELS WITH GUARD | 1,000 | In distribution | |
| No. 15C NON STERILE MINOR DISPOSABLE SCALPELS | 10 | In distribution | |
| No. 23 BULK NON STERILE RETRACTABLE SCALPELS | 500 | In distribution | |
| No. 24 BULK NON STERILE DISPOSABLE SCALPELS WITH GUARD | 1,000 | In distribution | |
| PARAGON No. 23 STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| PARAGON No. 15 STERILE DISPOSABLE SCALPEL WITH RETRACTING GUARD | 10 | In distribution | |
| LANCE No. 21 STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| No. 24 STERILE RETRACTABLE SCALPELS | 25 | In distribution | |
| PARAGON No. 24 STERILE DISPOSABLE SCALPEL WITH RETRACTING GUARD | 10 | In distribution | |
| No. 27 STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| No. 15 NON STERILE MINOR DISPOSABLE SCALPELS | 10 | In distribution | |
| BOX 100 No.15 NON STERILE MINOR DISPOSABLE SCALPELS | 100 | In distribution | |
| No. 10 STERILE RETRACTABLE SCALPELS | 25 | In distribution | |
| No.19 BULK NON STERILE DISPOSABLE SCALPELS WITH GUARD | 1,000 | In distribution | |
| NEUTRAL No. 11 NON STERILE DISPOSABLE SCALPELS | 100 | In distribution | |
| No. 24 BULK NON STERILE RETRACTABLE SCALPELS | 500 | In distribution | |
| No. 15C BULK NON STERILE RETRACTABLE SCALPELS | 500 | In distribution | |
| No. 24 NON STERILE DISPOSABLE SCALPEL WITH RETRACTING GUARD | 500 | In distribution | |
| No. 15T STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| No. 15A STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| No. 15 BULK NON STERILE RETRACTABLE SCALPELS | 500 | In distribution | |
| No. 10A STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| No. 23 STERILE DISPOSABLE SCALPELS WITH GUARD | 10 | In distribution | |
| No. 10 STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| No. 22 BULK NON STERILE RETRACTABLE SCALPELS | 500 | In distribution | |
| No. 14 STERILE RETRACTABLE SCALPELS | 25 | In distribution | |
| No. 10A BULK NON STERILE RETRACTABLE SCALPELS | 500 | In distribution | |
| SMITHS No.11 NON STERILE DISPOSABLE SCALPELS | 100 | In distribution | |
| No.12 BULK NON STERILE DISPOSABLE SCALPELS WITH GUARD | 1,000 | In distribution | |
| No. 26 STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| LANCE NO. 12 STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| No. 15 NON STERILE DISPOSABLE SCALPEL WITH RETRACTING GUARD | 500 | In distribution | |
| PARAGON No. 11 STERILE DISPOSABLE SCALPEL WITH RETRACTING GUARD | 10 | In distribution | |
| LANCE No. 10 STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| PARAGON No. 21 STERILE DISPOSABLE SCALPEL WITH RETRACTING GUARD | 10 | In distribution | |
| No. 11 STERILE DISPOSABLE SCALPEL WITH RETRACTING GUARD | 10 | In distribution | |
| No. 10R BULK NON STERILE RETRACTABLE SCALPEL S | 500 | In distribution | |
| SGD STERILE STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| No. 15 STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| No. 23 STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| PARAGON No. 22 STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| No. 22 STERILE RETRACTABLE SCALPELS | 25 | In distribution | |
| No. 22 STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| No. 22A STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| No. 15A NON STERILE MINOR DISPOSABLE SCALPELS | 10 | In distribution | |
| No. 22 STERILE DISPOSABLE SCALPEL WITH RETRACTING GUARD | 10 | In distribution | |
| No. 18 STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| No,14 BULK NON STERILE RETRACTABLE SCALPELS | 500 | In distribution | |
| LANCE No. 20 STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| No. 12 STERILE DISPOSABLE SCALPEL WITH RETRACTING GUARD | 500 | In distribution | |
| No. 25 STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| No. 11 NON STERILE DISPOSABLE SCALPEL WITH RETRACTING GUARD | 100 | In distribution | |
| No.10R STERILE RETRACTABLE SCALPELS | 10 | In distribution | |
| No. 22 NON STERILE DISPOSABLE SCALPEL WITH RETRACTING GUARD | 500 | In distribution | |
| No. 14 STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| No. 21 BULK NON STERILE DISPOSABLE SCALPELS WITH GUARD | 1,000 | In distribution | |
| LANCE No. 24 STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| LANCE No. 22 STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| No. 20 STERILE RETRACTABLE SCALPELS | 25 | In distribution | |
| No. 16 STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| No. 10 STERILE DISPOSABLE SCALPEL WITH RETRACTING GUARD | 10 | In distribution | |
| No. 11P NON STERILE DISPOSABLE SCALPEL WITH RETRACTING GUARD | 500 | In distribution | |
| No. 25A STERILE RETRACTABLE SCALPELS | 25 | In distribution | |
| PARAGON No. 22 STERILE DISPOSABLE SCALPEL WITH RETRACTING GUARD | 10 | In distribution | |
| No.22 STERILE RETRACTABLE SCALPELS | 10 | In distribution | |
| No. 12 STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| BOX 100 No.11 NON STERILE MINOR DISPOSABLE SCALPELS | 100 | In distribution | |
| No.23 STERILE RETRACTABLE SCALPELS | 10 | In distribution | |
| No. 11 STERILE DISPOSABLE SCALPELS WITH GUARD | 10 | In distribution | |
| PARAGON No. 15 STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| No. 15 STERILE RETRACTABLE SCALPELS | 25 | In distribution | |
| No. 11 BULK NON STERILE DISPOSABLE SCALPELS WITH GUARD | 1,000 | In distribution | |
| No.25A STERILE RETRACTABLE SCALPELS | 10 | In distribution | |
| No.15C STERILE RETRACTABLE SCALPELS | 10 | In distribution | |
| LANCE No. 11 STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| No.10A STERILE RETRACTABLE SCALPELS | 10 | In distribution | |
| No. 11P STERILE RETRACTABLE SCALPELS | 25 | In distribution | |
| PARAGON No. 15T STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| No. 25A STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| No. 20 BULK NON STERILE RETRACTABLE SCALPELS | 500 | In distribution | |
| PARAGON No. 10 STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| No. 24 STERILE DISPOSABLE SCALPELS WITH GUARD | 10 | In distribution | |
| No. 11 NON STERILE MINOR DISPOSABLE SCALPELS | 10 | In distribution | |
| PARAGON No. 24 STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| No. 24 STERILE DISPOSABLE SCALPEL WITH RETRACTING GUARD | 10 | In distribution | |
| BOX 100 No.10A NON STERILE MINOR DISPOSABLE SCALPELS | 100 | In distribution | |
| PARAGON No.12 NON STERILE DISPOSABLE SCALPELS | 100 | In distribution | |
| No. 11 STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| No. 21 STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| No. 20 STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| No. 10 STERILE DISPOSABLE SCALPELS WITH GUARD | 10 | In distribution | |
| PARAGON No. 12 STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| LANCE No. 23 STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| SMITHS No. 15 NON STERILE DISPOSABLE SCALPELS | 100 | In distribution | |
| No. 23 NON STERILE DISPOSABLE SCALPEL WITH RETRACTING GUARD | 500 | In distribution | |
| No. 10A NON STERILE MINOR DISPOSABLE SCALPELS | 10 | In distribution | |
| PARAGON No. 10 NON STERILE DISPOSABLE SCALPELS | 100 | In distribution | |
| No. 10A BULK NON STERILE DISPOSABLE SCALPELS WITH GUARD | 1,000 | In distribution | |
| No. 10 BULK NON STERILE DISPOSABLE SCALPEL WITH RETRACTING GUARD | 500 | In distribution | |
| No. 21 STERILE DISPOSABLE SCALPEL WITH RETRACTING GUARD | 10 | In distribution | |
| No. 15C STERILE RETRACTABLE SCALEPLS | 25 | In distribution | |
| No.24 STERILE RETRACTABLE SCALPELS | 10 | In distribution | |
| No.21 STERILE RETRACTABLE SCALPELS | 10 | In distribution | |
| No. 9 STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| No. 20 STERILE DISPOSABLE SCALPELS WITH GUARD | 10 | In distribution | |
| No. 15C STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| No. 23 STERILE RETRACTABLE SCALPELS | 25 | In distribution | |
| No. 20 STERILE DISPOSABLE SCALPEL WITH RETRACTING GUARD | 10 | In distribution | |
| No. 23 STERILE DISPOSABLE SCALPEL WITH RETRACTING GUARD | 10 | In distribution | |
| No. 6 STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| No.10A STERILE RETRACTABLE SCALPELS | 25 | In distribution | |
| No. 21 STERILE RETRACTABLE SCALPELS | 25 | In distribution | |
| No. 11P STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| No.15 STERILE RETRACTABLE SCALPELS | 10 | In distribution | |
| No. 21 BULK NON STERILE RETRACTABLE SCALPELS | 500 | In distribution | |
| No. 15 STERILE DISPOSABLE SCALPELS WITH GUARD | 10 | In distribution | |
| No. 11 BULK NON STERILE RETRACTABLE SCALPELS | 500 | In distribution | |
| LANCE BD No. 11 NON STERILE DISPOSABLE SCALPLES | 100 | In distribution | |
| No. 25A BULK NON STERILE RETRACTABLE SCALPELS | 500 | In distribution | |
| No. 21 STERILE DISPOSABLE SCALPELS WITH GUARD | 10 | In distribution | |
| No. 21 NON STERILE DISPOSABLE SCALPEL WITH RETRACTING GUARD | 500 | In distribution | |
| No. E11 STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| No. 12D STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| No. 20 NON STERILE DISPOSABLE SCALPEL WITH RETRACTING GUARD | 500 | In distribution | |
| SMITHS No. 10 NON STERILE DISPOSABLE SCALPELS | 100 | In distribution | |
| No. 22 STERILE DISPOSABLE SCALPELS WITH GUARD | 10 | In distribution | |
| No.14 STERILE RETRACTABLE SCALPELS | 10 | In distribution | |
| No.12 STERILE RETRACTABLE SCALPELS | 10 | In distribution | |
| No. 25A BULK NON STERILE DISPOSABLE SCALPELS WITH GUARD | 1,000 | In distribution | |
| No. 24 STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| No. 15 STERILE DISPOSABLE SCALPEL WITH RETRACTING GUARD | 10 | In distribution | |
| No. 10 BULK NON STERILE RETRACTABLE SCALPELS | 500 | In distribution | |
| No. 11P STERILE DISPOSABLE SCALPEL WITH RETRACTING GUARD | 10 | In distribution | |
| PARAGON No. 20 STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| No. 11P BULK NON STERILE DISPOSABLE SCALPELS WITH GUARD | 1,000 | In distribution | |
| No. 22 BULK NON STERILE DISPOSABLE SCALPELS WITH GUARD | 1,000 | In distribution | |
| No. 20 BULK NON STERILE DISPOSABLE SCALPELS WITH GUARD | 1,000 | In distribution | |
| PARAGON No. 11 NON STERILE DISPOSABLE SCALPELS | 100 | In distribution | |
| No. 19 STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| PARAGON No.10 STERILE DISPOSABLE SCALPEL WITH RETRACTING GUARD | 10 | In distribution | |
| No. 13 STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| No.10 STERILE RETRACTABLE SCALPELS | 10 | In distribution | |
| No.20 STERILE RETRACTABLE SCALPELS | 10 | In distribution | |
| No. 12 NON STERILE DISPOSABLE SCALPEL WITH RETRACTING GUARD | 500 | In distribution | |
| No.11P STERILE RETRACTABLE SCALPELS | 10 | In distribution | |
| PARAGON No. 23 STERILE DISPOSABLE SCALPEL WITH RETRACTING GUARD | 10 | In distribution | |
| LANCE No. 15T STERILE DISPOSABLE SCALPELS | 10 | In distribution | |
| No. 12 BULK NON STERILE RETRACTABLE SCALPELS | 500 | In distribution | |
| BOX 100 No.15A NON STERILE MINOR DISPOSABLE SCALPELS | 100 | In distribution | |
| PARAGON No. 23 NON STERILE DISPOSABLE SCALPELS | 100 | Withdrawn | |
| No. 12 STERILE DISPOSABLE SCALPELS WITH GUARD | 10 | Withdrawn | |
| No. 10A STERILE DISPOSABLE SCALPELS WITH GUARD | 10 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgistar | Surgistar, Inc. | 142 |
| Aesculap | Aesculap AG | 29 |
| Bard-Parker ® Safety Scalped | Aspen Surgical Products, Inc. | 19 |
| McKesson | Mckesson Medical-Surgical Inc. | 15 |
| Kiato Plus | Aditya Dispomed Products Private Ltd. | 15 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 15 |
| Sandel | Ansell Sandel Medical Solutions LLC | 14 |
| Sklar® | Sklar Corporation | 14 |
| Feather Disposable Scalpel | Feather Safety Razor Co., Ltd. | 14 |
| P&P Medical Surgical LLC | P&P Medical Surgical LLC | 14 |
| Bard-Parker ® Disposable Scalpels | Aspen Surgical Products, Inc. | 13 |
| Lumohs | Nano Surgical, Inc | 12 |
Showing 12 of 56. All products under Scalpel, One-Piece
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.