Sklar®
Simpson Luikart Obstetrical Forceps
2manufacturers in China registered for this device type
20catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Hangzhou Haizhu MIM Products Co., Ltd. | Hangzhou | Zhejiang | Exporter | 28 |
Record
| Listed by | Sklar Corporation, United States |
|---|---|
| FDA product code | HDA |
| Device type | Forceps, Obstetrical |
| Device class | Class 2 |
| Regulation | 21 CFR 884.4400 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K092827 |
| Record published | 2016-11-01 |
| Record revised | 2019-02-07 (version 4) |
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 |
|---|---|---|
| 92-1915 | In distribution | |
| 92-2314 | In distribution | |
| 92-3215 | In distribution | |
| 92-2812 | In distribution | |
| 92-1712 | In distribution | |
| 92-1112 | In distribution | |
| 92-2915 | In distribution | |
| 92-2415 | In distribution | |
| 92-2015 | In distribution | |
| 92-2717 | In distribution | |
| 92-1415 | In distribution | |
| 92-2115 | In distribution | |
| 92-1014 | In distribution | |
| 92-1114 | In distribution | |
| 92-3360 | In distribution | |
| 92-2912 | In distribution | |
| 92-1012 | In distribution | |
| 92-1814 | In distribution | |
| 92-2215 | In distribution | |
| 92-3350 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Millennium | Avalign Technologies, Inc. | 40 |
| Novo Surgical | Novo Surgical, Inc. | 30 |
| Hayden Medical | Hayden Medical Inc | 18 |
| Aesculap | Aesculap AG | 18 |
| Avalign | Avalign Technologies, Inc. | 17 |
| Ambler Surgical | Ambler Surgical, LLC | 14 |
| Pilling | Teleflex Medical LLC | 14 |
| Pilling | Avalign Technologies, Inc. | 11 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 11 |
| V. Mueller | Steris Corporation | 9 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 8 |
| Realstar Surgical | Real Star Surgical Instruments | 4 |
Showing 12 of 34. All products under Forceps, Obstetrical
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.