GEN2

Walther Dilator-Catheters 24 Fr Female, Overall Length 5-1/4" (13.3cm)

Registry build 21.09.26
3manufacturers in China registered for this device type
47catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (1), Shandong (1), Zhejiang (1).

Chinese manufacturers registered for FDA product code HDQ
Manufacturer City Province Registered as Device types
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Wenzhou LW Wewear Accessories Co., Ltd. Wenzhou Zhejiang Private-label distributor 2

Record

Regulatory record for GEN2
Listed by Surgix Medical LLC, United States
FDA product code HDQ
Device type Dilator, Cervical, Fixed Size
Device class Class 1
Regulation 21 CFR 884.4530
Establishment Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2023-08-09

Specifications

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
Sizes Length 5.25 to 13.75 in; catheter gauge 12 to 38 Fr

Catalogue Numbers

Catalogue numbers for GEN2
Catalogue number Size Status
G2OB1588 Length 8 in In distribution
G2OB1581 Length 11.5 in In distribution
G2OB1612 Length 5.25 in In distribution
G2OB1609 Length 5.25 in In distribution
G2OB1629 Length 13.75 in In distribution
G2OB1608 Length 5.25 in In distribution
G2OB1465 In distribution
G2OB1634 Length 13.75 in In distribution
G2OB1635 Length 13.75 in In distribution
G2OB1587 Length 8 in In distribution
G2OB1592 Length 8 in In distribution
G2OB1590 Length 8 in In distribution
G2OB1579 Length 11.5 in In distribution
G2OB1633 Length 13.75 in In distribution
G2OB1613 Length 5.25 in In distribution
G2OB1463 In distribution
G2OB1610 Length 5.25 in In distribution
G2OB1638 Length 13.75 in In distribution
G2OB1631 Length 13.75 in In distribution
G2OB1615 Length 5.25 in In distribution
G2OB1607 Length 5.25 in In distribution
G2OB1619 Length 5.25 in In distribution
G2OB1582 Length 11.5 in In distribution
G2OB1611 Length 5.25 in In distribution
G2OB1578 Length 11.5 in In distribution
G2OB1461 In distribution
G2OB1586 Length 8 in In distribution
G2OB1464 In distribution
G2OB1535 Length 13.375 in In distribution
G2OB1606 Length 5.25 in In distribution
G2OB1577 Length 11.5 in In distribution
G2OB1636 Length 13.75 in In distribution
G2OB1462 In distribution
G2OB1585 Length 8 in In distribution
G2OB1632 Length 13.75 in In distribution
G2OB1466 In distribution
G2OB1583 Length 11.5 in In distribution
G2OB1616 Length 5.25 in In distribution
G2OB1591 Length 8 in In distribution
G2OB1584 Length 11.5 in In distribution
G2OB1617 Length 5.25 in In distribution
G2OB1614 Length 5.25 in In distribution
G2OB1630 Length 13.75 in In distribution
G2OB1637 Length 13.75 in In distribution
G2OB1589 Length 8 in In distribution
G2OB1618 Length 5.25 in In distribution
G2OB1580 Length 11.5 in In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Hayden Medical Hayden Medical Inc 184
Millennium Avalign Technologies, Inc. 181
Elmed Incorporated Elmed, Inc. 152
Marina Medical Marina Medical Instruments, Inc. 142
Elmed Elmed, Inc. 138
Novo Surgical Inc. Novo Surgical, Inc. 129
Ambler Surgical Ambler Surgical, LLC 103
Integra® Miltex® Integra LifeSciences Production Corporation 100
Aesculap Aesculap AG 98
Integra® Jarit® Integra LifeSciences Production Corporation 77
Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft 73
V. Mueller Steris Corporation 65

Showing 12 of 104. All products under Dilator, Cervical, Fixed Size

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