Baltaxe-Mitty-Pollack

Disposable Baltaxe-Mitty-Pollack Coaxial Needle Set

Registry build 21.09.26
1manufacturer
1catalogue number

Who Else Makes It

Registered in Zhejiang.

Chinese manufacturers registered for FDA product code FBQ
Manufacturer City Province Registered as Device types
Hangzhou Endo Medical Instrument Co., Ltd. Hangzhou Zhejiang Contract manufacturer 19

Record

Regulatory record for Baltaxe-Mitty-Pollack
Listed by Cook Incorporated, United States
FDA product code FBQ
Device type Trocar, Gastro-Urology
Device class Class 2
Regulation 21 CFR 876.5090
Establishment Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2017-08-22
Record revised 2018-03-29 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date
Storage Special storage condition: Store in dark, dry, cool place.

Catalogue Numbers

Catalogue numbers for Baltaxe-Mitty-Pollack
Catalogue number Size Status
G03593 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Busse Hospital Disposables Robert Busse & Co., Inc. 62
Riwo-ART Richard Wolf Gmbh 52
Trocar, Gastro-Urology Richard Wolf Gmbh 43
Doctor Nice B. ALI Impex 23
MIP Minimal Invasive Pcnl Karl Storz GmbH & Co. KG 6
Spring Grip Covidien LP 6
Integra® Miltex® Integra LifeSciences Production Corporation 6
Trotec Richard Wolf Gmbh 6
Trocar, Gastro-Urology Karl Storz GmbH & Co. KG 5
Cook Cook Incorporated 5
EchoTip Cook Incorporated 3
Strauss Surgical American Medical Endoscopy 3

Showing 12 of 19. All products under Trocar, Gastro-Urology

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer