Aesculap
PERKINS Wound Retractor, self-retaining, 5", (125 mm), serrated (coarse), solid blade right, non-sterile, reusable
3manufacturers in China registered for this device type
46catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), 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 |
| Shanghai Wilpower Industrial Co., Ltd. | Shanghai | Shanghai | Exporter | 33 |
Record
| Listed by | Aesculap AG, Germany |
|---|---|
| FDA product code | KAL |
| Device type | Retractor, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-05-07 |
| Record revised | 2023-08-24 (version 4) |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MA424R | In distribution | |
| OM111R | In distribution | |
| MA430R | In distribution | |
| MA433R | In distribution | |
| OM114R | In distribution | |
| OM175R | In distribution | |
| OM112R | In distribution | |
| OK794R | In distribution | |
| MG810R | In distribution | |
| OL219R | In distribution | |
| BV093R | In distribution | |
| MA438R | In distribution | |
| OK795R | In distribution | |
| MA426R | In distribution | |
| OM253R | In distribution | |
| OM252R | In distribution | |
| MA428R | In distribution | |
| MA432R | In distribution | |
| BT120R | In distribution | |
| MA431R | In distribution | |
| OM174R | In distribution | |
| OM178R | In distribution | |
| OL210R | In distribution | |
| OM176R | In distribution | |
| MA422R | In distribution | |
| MA423R | In distribution | |
| OM172R | In distribution | |
| MB107R | In distribution | |
| MA427R | In distribution | |
| MA608R | In distribution | |
| OM182R | In distribution | |
| OL220R | In distribution | |
| MA429R | In distribution | |
| OM173R | In distribution | |
| MB748R | In distribution | |
| OL221R | In distribution | |
| OK103R | In distribution | |
| OM177R | In distribution | |
| MB054R | In distribution | |
| OM115R | In distribution | |
| OM181R | In distribution | |
| OM113R | In distribution | |
| OM183R | In distribution | |
| OM171R | In distribution | |
| MG659R | In distribution | |
| OM251R | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| V. Mueller | Steris Corporation | 138 |
| Ambler Surgical | Ambler Surgical, LLC | 105 |
| Pilling | Teleflex Medical LLC | 90 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 89 |
| Boss Instruments | Boss Instruments, Ltd. | 61 |
| Avalign | Avalign Technologies, Inc. | 54 |
| Fentex | Fentex medical GmbH | 54 |
| Novo Surgical | Novo Surgical, Inc. | 52 |
| Millennium | Avalign Technologies, Inc. | 47 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 43 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 42 |
| HNM Medical | HNM Stainless, LLC. | 39 |
Showing 12 of 80. All products under Retractor, Ent
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.