Aesculap
MC IVOR Ring Retractor, blade, right, Fig. 3, depth: 29 mm, width: 77 mm, non-sterile, reusable
12manufacturers in China registered for this device type
41catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (4), Guangdong (3), Shanghai (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Ningbo Chibanda IMP &EXP Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 59 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Changzhou Meiguan Care Products Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 32 |
| Changzhou Major Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 31 |
| Foshan Hongfeng Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 24 |
| Shenzhen JPY ION-Tech. Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 20 |
| Jiangsu Kangjin Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 13 |
| Shenzhen Golden Wish Personal Care Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 10 |
Record
| Listed by | Aesculap AG, Germany |
|---|---|
| FDA product code | KBN |
| Device type | Gag, Mouth |
| 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 | 2020-04-22 |
| Record revised | 2023-08-22 (version 3) |
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 |
| Distribution end date | 2024-11-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OM185R | In distribution | |
| MA314R | In distribution | |
| MA304R | In distribution | |
| MG949R | In distribution | |
| OM040R | In distribution | |
| MA312R | In distribution | |
| OM073R | In distribution | |
| OM049R | In distribution | |
| MG475R | In distribution | |
| OM063R | In distribution | |
| MA300R | In distribution | |
| MA309R | In distribution | |
| MA305R | In distribution | |
| OM030R | In distribution | |
| OM061R | In distribution | |
| MA310R | In distribution | |
| OM105R | In distribution | |
| OM072R | In distribution | |
| MA306R | In distribution | |
| OM048R | In distribution | |
| MA315R | In distribution | |
| MA311R | In distribution | |
| OM047R | In distribution | |
| MA313R | In distribution | |
| MA301R | In distribution | |
| OM070R | In distribution | |
| OM041R | In distribution | |
| OM038R | In distribution | |
| MG948R | In distribution | |
| OM071R | In distribution | |
| MA319R | In distribution | |
| MA308R | In distribution | |
| OM062R | In distribution | |
| OM044R | In distribution | |
| MA307R | In distribution | |
| MB599R | Withdrawn | |
| MB598R | Withdrawn | |
| MB596R | Withdrawn | |
| MB600R | Withdrawn | |
| MB597R | Withdrawn | |
| MB595R | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 74 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 60 |
| Sklar® | Sklar Corporation | 55 |
| Millennium | Avalign Technologies, Inc. | 51 |
| Ambler Surgical | Ambler Surgical, LLC | 49 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 43 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 41 |
| V. Mueller | Steris Corporation | 39 |
| Novo Surgical | Novo Surgical, Inc. | 38 |
| Avalign | Avalign Technologies, Inc. | 33 |
| Integra® | Integra LifeSciences Production Corporation | 31 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 29 |
Showing 12 of 99. All products under Gag, Mouth
Recalls
1 of these is Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Closed |
|---|---|---|---|---|
| 2018-02-16 | Class III | Mixed-up of materials/components | The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable. | 2020-06-30 |
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.