What is FDA product code NWV?

Exempt laparoscope accessories are non-powered, non-inflatable, simple manual mechanical devices, e.g., cannula, graspers, forceps, dissectors, scissors, etc. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.

Obstetrics & Gynecology › DiagnosticLaparoscopic Accessories, Gynecologic

Axial Needle Holder, 3MM X 30CM, Right Curved JAW

Name: Axial Needle Holder, 3MM X 30CM, Right Curved JAW
Brand: Axial Needle Holder, 3MM X 30CM, Right Curved JAW

A hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing.

Registry build 21.09.26

7manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Zhejiang (3), Anhui (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code NWV
Manufacturer	City	Province	Registered as	Device types
Tonglu Qianyan Medtech Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	7
Hangzhou Endo Medical Instrument Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	19
Anhui Shiyin Photoelectric Instrument Co., Ltd.	Suzhou	Anhui	Specification developer	18
Tonglu Youshi Medical Instrument Co., Ltd.	Tonglu	Zhejiang	Manufacturer	10
Anqing Changfan Medical Instrument Co., Ltd.	Anqing	Anhui	Manufacturer	9
Suzhou SMH Co., Ltd.	Suzhou	Jiangsu	Manufacturer	4
Hunan Handlike Minimally Invasive Surgery Co., Ltd.	Changsha	Hunan	Manufacturer	3

Record

Regulatory record for Axial Needle Holder, 3MM X 30CM, Right Curved JAW
Listed by	National Advanced Endoscopy Devices, Inc., United States
FDA product code	NWV
Device type	Laparoscopic Accessories, Gynecologic
Device class	Class 1
Regulation	21 CFR 884.1720
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer
Premarket notification	Exempt
Record published	2023-04-24

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, manufacturing date

Catalogue Numbers

Catalogue numbers for Axial Needle Holder, 3MM X 30CM, Right Curved JAW
Catalogue number	Size	Status
SZM1594		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Millennium	Avalign Technologies, Inc.	201
AED	National Advanced Endoscopy Devices, Inc.	173
Elmed	Elmed, Inc.	36
Elite	National Advanced Endoscopy Devices, Inc.	8
Elmed Incorporated	Elmed, Inc.	7
AbGrab	Lapovations, LLC	6
Integra® Jarit®	Integra LifeSciences Production Corporation	5
Laparoscopic Accessories, Gynecologic	Stryker Sustainability Solutions	5
Speedlock	National Advanced Endoscopy Devices, Inc.	5
TroClear	Mednium Corporation	5
Integra® Miltex®	Integra LifeSciences Production Corporation	5
Eco Fit	National Advanced Endoscopy Devices, Inc.	4

Showing 12 of 80. All products under Laparoscopic Accessories, Gynecologic

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.