Home GUDID 00860004002116 FlexDex Needle Driver
Primary DI 00860004002116
Brand FlexDex Needle Driver
Company FlexDex Surgical
Model FD-335 ND
Published 2022-08-19
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name MDM Instrument, Manual, Surgical, General Use
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860004002116 Package GS1 3 In Commercial Distribution 00860004002109 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00860004002116 00860004002116 860004002116 0860004002116 00860004002109 00860004002109 860004002109 0860004002109
GMDN Terms# Term, Definition table Term Definition Suturing needle holder, single-use A hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It has short serrated jaws at the distal end to provide better grip of the needle, and is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. This is a single-use device.
Regulatory Flags# DUNS number 967741179 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00860004002130 AXIUS 8mm Needle Driver - Medium 8ND1M 2023-06-16 00860004002147 AXIUS 8mm Needle Driver - Long 8ND1L 2023-06-16 00860004002109 FlexDex Needle Driver FD-335 ND 2022-08-19
Other Devices Sharing Product Codes#