Home GUDID 00815384022063
OPTICS ONE
Primary DI 00815384022063
Brand OPTICS ONE
Company MEDICAL TECHNIQUE, INC.
Model 8902-120
Catalog number 8902-120
Device description Generic Microscope/Laser/Camera Cover 42 x 120 2 piece
Published 2016-09-24
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 true
Product Codes# Code, Name table Code Name HMW Drape, Microscope, Ophthalmic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HMW Drape, Microscope, Ophthalmic General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00815384022056 Package GS1 5 In Commercial Distribution 00815384022063 Package GS1 2 In Commercial Distribution 00815384022049 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 00815384022056 00815384022056 815384022056 0815384022056 00815384022063 00815384022063 815384022063 0815384022063 00815384022049 00815384022049 815384022049 0815384022049
GMDN Terms# Term, Definition table Term Definition Instrument/equipment drape, single-use, sterile A sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various surgical and/or non-surgical instruments/equipment [e.g., surgical tray, operating room (OR) equipment table, endoscope and endoscopic instruments, surgical cameras and lasers], to provide a barrier against cross-contamination in various clinical settings. This is a single-use device.
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 790514756 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 true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00810123208616 Adler Instrument Company Adler, Inc. HMW 2025-02-18 00810123208135 Adler Instrument Company Adler, Inc. HMW 2024-12-13 00840277124739 Innomed, Inc. INNOMED, INC. HMW 2020-01-31 00027479193194 SpandaGrip MEDI-TECH INTERNATIONAL CORPORATION HMW 2019-07-01 04048438005170 n.a. Karl Storz GmbH & Co. KG HMW 2018-08-21 00852205007892 Exact Medical Manufacturing, Inc. EXACT MEDICAL MANUFACTURING, INC. HMW 2017-10-24 00852205007922 Exact Medical Manufacturing, Inc. EXACT MEDICAL MANUFACTURING, INC. HMW 2017-10-24 00852205007915 Exact Medical Manufacturing EXACT MEDICAL MANUFACTURING, INC. HMW 2017-10-24 00852205007946 Exact Medical Manufacturing EXACT MEDICAL MANUFACTURING, INC. HMW 2017-10-24 10885403067532 V. Mueller CAREFUSION 2200, INC HMW 2017-10-17 10885403133893 V. Mueller CAREFUSION 2200, INC HMW 2017-10-17 10885403067600 V. Mueller CAREFUSION 2200, INC HMW 2017-10-17 20885403067539 V. Mueller CAREFUSION 2200, INC HMW 2017-10-17 20885403133890 V. Mueller CAREFUSION 2200, INC HMW 2017-10-17 00190769003555 Vashe Sterile Sleeve URGO MEDICAL NORTH AMERICA, LLC HMW 2017-07-17 10190769003552 Vashe Sterile Sleeve URGO MEDICAL NORTH AMERICA, LLC HMW 2017-07-17 04049539103536 Sterilizable Metal Sleeve Carl Zeiss Meditec AG HMW 2017-05-04 04049539102454 2-Pack Asepsis VISULUX Carl Zeiss Meditec AG HMW 2017-05-04 04049539103284 Sterilizable Metal Sleeve Carl Zeiss Meditec AG HMW 2017-05-04 00815384021004 OPTICS ONE MEDICAL TECHNIQUE, INC. HMW 2016-09-24 00815384021035 OPTICS ONE MEDICAL TECHNIQUE, INC. HMW 2016-09-24 00815384021066 OPTICS ONE MEDICAL TECHNIQUE, INC. HMW 2016-09-24 00815384021097 OPTICS ONE MEDICAL TECHNIQUE, INC. HMW 2016-09-24 00815384021127 OPTICS ONE MEDICAL TECHNIQUE, INC. HMW 2016-09-24 00815384021158 OPTICS ONE MEDICAL TECHNIQUE, INC. HMW 2016-09-24 00815384021189 OPTICS ONE MEDICAL TECHNIQUE, INC. HMW 2016-09-24 00815384021240 OPTICS ONE MEDICAL TECHNIQUE, INC. HMW 2016-09-24 00815384021271 OPTICS ONE MEDICAL TECHNIQUE, INC. HMW 2016-09-24 00815384021301 OPTICS ONE MEDICAL TECHNIQUE, INC. HMW 2016-09-24 00815384021332 OPTICS ONE MEDICAL TECHNIQUE, INC. HMW 2016-09-24