Sklar
Guttmann Secretion Scoop 10.5 Inches
2manufacturers in China registered for this device type
21catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
Record
| Listed by | Sklar Corporation, United States |
|---|---|
| FDA product code | FHL |
| Device type | Scoop |
| Device class | Class 1 |
| Regulation | 21 CFR 876.4730 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-03-19 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 32-1016 | In distribution | |
| 32-1060 | In distribution | |
| 32-3094 | In distribution | |
| 32-3096 | In distribution | |
| 32-1014 | In distribution | |
| 32-1057 | In distribution | |
| 32-1010 | In distribution | |
| 32-3098 | In distribution | |
| 32-1052 | In distribution | |
| 32-3092 | In distribution | |
| 32-1055 | In distribution | |
| 32-1053 | In distribution | |
| 32-1036 | In distribution | |
| 32-1015 | In distribution | |
| 32-1054 | In distribution | |
| 32-1040 | In distribution | |
| 32-1056 | In distribution | |
| 32-1050 | In distribution | |
| 32-1051 | In distribution | |
| 32-1035 | In distribution | |
| 32-1037 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Aesculap | Aesculap AG | 18 |
| V. Mueller | Steris Corporation | 13 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 12 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 11 |
| Ambler Surgical | Ambler Surgical, LLC | 11 |
| Novo Surgical | Novo Surgical, Inc. | 8 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 7 |
| Gimmi | Gimmi Gmbh | 6 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 6 |
| Symmetry Desjardins | Aspen Surgical Products, Inc. | 4 |
| Anmuth Medical International | Anmuth Medical International LLC | 4 |
| Davis Gall Stone Scoop | Sontec Instruments, Inc. | 3 |
Showing 12 of 21. All products under Scoop
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.