Aesculap
PRATT Uterine Dressing Forceps, straight, 10 5/8", (270 mm), toothed (4x4), screw lock, width: 22 mm, non-sterile, reusable
4manufacturers in China registered for this device type
52catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1), Jiangsu (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 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
Record
| Listed by | Aesculap AG, Germany |
|---|---|
| FDA product code | HGC |
| Device type | Clamp, Uterine |
| Device class | Class 1 |
| Regulation | 21 CFR 884.4520 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-04-21 |
| Record revised | 2023-08-25 (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 | 2024-06-15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EO077R | In distribution | |
| EO106R | In distribution | |
| BJ540R | In distribution | |
| BJ560R | In distribution | |
| EO130R | In distribution | |
| EO216R | In distribution | |
| EO166R | In distribution | |
| BJ534R | In distribution | |
| EO180R | In distribution | |
| MG766R | In distribution | |
| BJ532R | In distribution | |
| BJ511R | In distribution | |
| EO060R | In distribution | |
| BJ574R | In distribution | |
| EO105R | In distribution | |
| EO082R | In distribution | |
| BJ520R | In distribution | |
| EO125R | In distribution | |
| BJ524R | In distribution | |
| BJ530R | In distribution | |
| BJ579R | In distribution | |
| EO061R | In distribution | |
| BJ500R | In distribution | |
| EO110R | In distribution | |
| EO085R | In distribution | |
| BJ501R | In distribution | |
| EO202R | In distribution | |
| EO108R | In distribution | |
| EO080R | In distribution | |
| EO075R | In distribution | |
| EO165R | In distribution | |
| MD592 | In distribution | |
| EO150R | In distribution | |
| BJ521R | In distribution | |
| MD591 | In distribution | |
| BJ531R | In distribution | |
| BJ541R | In distribution | |
| EO164R | In distribution | |
| BJ561R | In distribution | |
| EO151R | In distribution | |
| BJ527R | In distribution | |
| ET268R | In distribution | |
| EO122R | In distribution | |
| EO140R | In distribution | |
| ET269R | In distribution | |
| BJ522R | In distribution | |
| EO163R | In distribution | |
| EO111R | In distribution | |
| BJ510R | In distribution | |
| BJ526R | Withdrawn | |
| BJ576R | Withdrawn | |
| MB102R | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Novo Surgical Inc | Novo Surgical, Inc. | 114 |
| Novo Surgical | Novo Surgical, Inc. | 97 |
| Hayden Medical | Hayden Medical Inc | 80 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 46 |
| V. Mueller | Steris Corporation | 35 |
| Millennium | Avalign Technologies, Inc. | 15 |
| HNM Medical | HNM Stainless, LLC. | 12 |
| Intrace USA | Pilotis Tech LLC | 7 |
| Ambler Value Line | Ambler Surgical, LLC | 6 |
| Forceps | KLS-Martin L.P. | 6 |
| Atraumata | Aesculap AG | 5 |
| Pilling | Teleflex Medical LLC | 5 |
Showing 12 of 16. All products under Clamp, Uterine
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2025-01-31 | Class II | Use error | The forceps have been used in ways not covered by the design resulting in breakage of the clamps. | 19,979 forceps |
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.