Home GUDID 05050474520493 AMO LIMBAL NEEDLE ASSEMBLY
Primary DI 05050474520493
Brand AMO LIMBAL NEEDLE ASSEMBLY
Company JOHNSON & JOHNSON SURGICAL VISION, INC.
Model OM0504011
Catalog number OM0504011
Device description PARTS LIST, LIMBAL NEEDLE ASSEMBLY
Published 2016-09-02
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use false Product Codes# Code, Name table Code Name HKP INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, BATTERY-POWERED
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HKP Instrument, Vitreous Aspiration And Cutting, Battery-Powered Ophthalmic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05050474520493 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05050474520493 05050474520493 5050474520493
GMDN Terms# Term, Definition table Term Definition Vitrectomy system handpiece A holder for a detachable, micro-cutting tip that converts the energy (e.g., ultrasonic, piezoelectric) produced by a system generator into a mechanical oscillating-cutting action to remove (nibble away) vitreous humour (the jelly-like substance that fills the centre of the eye) during ophthalmic surgery. This device will typically be activated by the surgeon using a foot control and provide or support the irrigation/suction systems needed to supply replacement fluid and remove debris. The handpiece is typically designed in the form of a pen or pencil, and connected to the generator via a cable. This is a reusable device intended to be sterilized prior to use.
Regulatory Flags# DUNS number 103021940 Device count 1 DM exempt true Premarket exempt false 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00812480010307 NA MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. HKP 2017-06-24 00812480010314 NA MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. HKP 2017-06-24 00852475007004 Insight Instruments, Inc. Vitreous Biopsy Probe 27 Ga INSIGHT INSTRUMENTS, INC. HKP 2016-09-23 00852475007011 Insight Instruments, Inc. Vitreous Biopsy Probe 27 Ga INSIGHT INSTRUMENTS, INC. HKP 2016-09-23 00856222004186 INTRECTOR® INSIGHT INSTRUMENTS, INC. HKP 2016-09-23 00856222004193 INTRECTOR® INSIGHT INSTRUMENTS, INC. HKP 2016-09-23 00856222004643 INTRECTOR® INSIGHT INSTRUMENTS, INC. HKP 2016-09-23 00856222004667 RETRECTOR® INSIGHT INSTRUMENTS, INC. HKP 2016-09-23 00812480010215 NA MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. HKP 2016-09-23 00812480010222 NA MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. HKP 2016-09-23 00812480010277 NA MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. HKP 2016-09-23 00812480010949 NA MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. HKP 2016-09-23 00812480010956 NA MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. HKP 2016-09-23 00812480010963 NA MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. HKP 2016-09-23 05050474520479 AMO TAC VITRECTOMY HANDPIECE JOHNSON & JOHNSON SURGICAL VISION, INC. HKP 2016-09-02 05050474520509 AMO TAC INFUSION SLEEVE JOHNSON & JOHNSON SURGICAL VISION, INC. HKP 2016-09-02
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