Echotip

Echotip Disposable Amniocentesis Needle

Registry build 21.09.26
1manufacturer
23catalogue numbers in this listing

Who Else Makes It

Registered in Jiangsu.

Chinese manufacturers registered for FDA product code HIO
Manufacturer City Province Registered as Device types
Changzhou Meiguan Care Products Technology Co., Ltd. Changzhou Jiangsu Manufacturer 32

Record

Regulatory record for Echotip
Listed by Cook Incorporated, United States
FDA product code HIO
Device type Sampler, Amniotic Fluid (Amniocentesis Tray)
Device class Class 1
Regulation 21 CFR 884.1550
Establishment Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2020-10-02

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.
Packaging Pack of 10

Catalogue Numbers

Catalogue numbers for Echotip
Catalogue number Size Status
G16283 In distribution
G16307 In distribution
G16310 In distribution
G16308 In distribution
G16298 In distribution
G35572 In distribution
G16304 In distribution
G16300 In distribution
G16288 In distribution
G16289 In distribution
G16294 In distribution
G16297 In distribution
G16309 In distribution
G16299 In distribution
G16303 In distribution
G16275 In distribution
G16284 In distribution
G16276 In distribution
G16287 In distribution
G16291 In distribution
G35573 In distribution
G16290 In distribution
G18203 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Cardinal Health Cardinal Health 200, LLC 82
Aligned Medical Solutions Aligned Medical Solutions 9
Amniocentesis Tray Argon Medical Devices, Inc. 3
Stradis Healthcare Stradis Healthcare 2
Amniocentesis Needle Vitrolife Sweden AB 2
Amnicators Medical Wire & Equipment Company (Bath), Ltd. 2
Busse Hospital Disposables Robert Busse & Co., Inc. 2
AmnioTest (Nitrazine yellow swab) pro-lab incorporated 1
Sampler, Amniotic Fluid (Amniocentesis Tray) Carefusion 2200, Inc. 1
Stradis Stradis Healthcare 1
AmnioTest (Nitrazine yellow swab 100 box) pro-lab incorporated 1
DeRoyal Deroyal Industries, Inc. 1

Showing 12 of 17. All products under Sampler, Amniotic Fluid (Amniocentesis Tray)

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