Who else makes this device?

Name: Midi-Size
Brand: Midi-Size

Gastroenterology & Urology › DiagnosticResectoscope

Midi-Size

OBTURATOR RESECTOSCOPE 14.5FR color code white, WL 240 mm, oval, rounded distal end, compatible with sheath 86770155, reusable

Registry build 21.09.26

1manufacturer

1catalogue number

1recall

Who Else Makes It

Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code FJL
Manufacturer	City	Province	Registered as	Device types
Peter’s Technology (Suzhou) Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	9

Record

Regulatory record for Midi-Size
Listed by	Richard Wolf Gmbh, Germany
FDA product code	FJL
Device type	Resectoscope
Device class	Class 2
Regulation	21 CFR 876.1500
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter
Record published	2016-09-26
Record revised	2024-12-02 (version 7)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Label carries	lot or batch number, manufacturing date
Storage	Storage environment humidity 10 to 90 % RH; Storage environment temperature -20 to 60 °C
Sizes	Outer diameter 4.83333 mm

Catalogue Numbers

Catalogue numbers for Midi-Size
Catalogue number	Size	Status
86770157	Outer Diameter 4.83333333333 mm	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Olympus	Olympus Winter & IBE Gmbh	58
E-Line	Richard Wolf Gmbh	33
Ureterorenoscope	Sopro-Comeg GmbH	28
AED	National Advanced Endoscopy Devices, Inc.	24
Shark	Richard Wolf Gmbh	21
Urology syringe	Sopro-Comeg GmbH	15
Resectoscope	Richard Wolf Gmbh	14
Resectoscope	Karl Storz GmbH & Co. KG	11
Panoview	Richard Wolf Gmbh	8
Urology Evacuator	Sopro-Comeg GmbH	7
Piranha	Richard Wolf Gmbh	6
Veloxion	Aulea Medical, Inc.	6

Showing 12 of 18. All products under Resectoscope

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.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2021-06-25	Class II	Under Investigation by firm	Product labeled as Cutting Electrode may contain BIVAP electrode.	20 boxes	2024-01-05

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.