FDA.reportPublic FDA data

OPTICS ONE

Primary DI
00815384021035
Brand
OPTICS ONE
Company
MEDICAL TECHNIQUE, INC.
Model
4920-62
Catalog number
4920-62
Device description
Zeiss OpMi Microscope Drape 20 x 62
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HMWDrape, Microscope, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMWDrape, Microscope, OphthalmicGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815384021042PackageGS110In Commercial Distribution
00815384021059PackageGS12In Commercial Distribution
00815384021035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815384021042008153840210428153840210420815384021042
00815384021059008153840210598153840210590815384021059
00815384021035008153840210358153840210350815384021035

GMDN Terms#

Term, Definition table
TermDefinition
Instrument/equipment drape, single-use, sterileA 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

Contacts#

Phone, Email table
PhoneEmail
520-733-7999INFO@MTIDRAPE.COM

Regulatory Flags#

DUNS number
790514756
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815384020670Medical Resources Group LimitedMRG100MRG1002021-09-27
10815384020677Medical Resources Group LimitedMRG100MRG1002021-09-27
00815384023237OPTICS ONEMTI-3030MTI-30302016-09-24
00815384023282OPTICS ONEMTI-4040MTI-40402016-09-24
00815384023596OPTICS ONE4335-204335-202018-06-21
00815384020007OPTICS ONE1012-401012-402016-09-23
00815384020038OPTICS ONE1215-ZIP1215-ZIP2016-09-23
00815384020069OPTICS ONE1288-201288-202016-09-23
00815384020083OPTICS ONE1289-201289-202016-09-23
00815384020106OPTICS ONE1290-201290-202016-09-23
00815384020120OPTICS ONE1292-201292-202016-09-23
00815384020144OPTICS ONE1295-201295-202016-09-23
00815384020168OPTICS ONE272227222016-09-23
00815384020199OPTICS ONE3279-503279-502016-09-23
00815384020212OPTICS ONE4336-204336-202016-09-23
00815384020243OPTICS ONE4337-204337-202016-09-23
00815384020274OPTICS ONE4338-204338-202016-09-23
00815384020304OPTICS ONE4339-204339-202016-09-23
00815384020335OPTICS ONE4701-304701-302016-09-23
00815384020366OPTICS ONE4705-404705-402016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810123208616Adler Instrument CompanyAdler, Inc.HMW2025-02-18
00810123208135Adler Instrument CompanyAdler, Inc.HMW2024-12-13
00840277124739Innomed, Inc.INNOMED, INC.HMW2020-01-31
00027479193194SpandaGripMEDI-TECH INTERNATIONAL CORPORATIONHMW2019-07-01
04048438005170n.a.Karl Storz GmbH & Co. KGHMW2018-08-21
00852205007892Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.HMW2017-10-24
00852205007922Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.HMW2017-10-24
00852205007915Exact Medical ManufacturingEXACT MEDICAL MANUFACTURING, INC.HMW2017-10-24
00852205007946Exact Medical ManufacturingEXACT MEDICAL MANUFACTURING, INC.HMW2017-10-24
10885403067532V. MuellerCAREFUSION 2200, INCHMW2017-10-17
10885403133893V. MuellerCAREFUSION 2200, INCHMW2017-10-17
10885403067600V. MuellerCAREFUSION 2200, INCHMW2017-10-17
20885403067539V. MuellerCAREFUSION 2200, INCHMW2017-10-17
20885403133890V. MuellerCAREFUSION 2200, INCHMW2017-10-17
00190769003555Vashe Sterile SleeveURGO MEDICAL NORTH AMERICA, LLCHMW2017-07-17
10190769003552Vashe Sterile SleeveURGO MEDICAL NORTH AMERICA, LLCHMW2017-07-17
04049539103536Sterilizable Metal SleeveCarl Zeiss Meditec AGHMW2017-05-04
040495391024542-Pack Asepsis VISULUXCarl Zeiss Meditec AGHMW2017-05-04
04049539103284Sterilizable Metal SleeveCarl Zeiss Meditec AGHMW2017-05-04
00815384021004OPTICS ONEMEDICAL TECHNIQUE, INC.HMW2016-09-24
00815384021066OPTICS ONEMEDICAL TECHNIQUE, INC.HMW2016-09-24
00815384021097OPTICS ONEMEDICAL TECHNIQUE, INC.HMW2016-09-24
00815384021127OPTICS ONEMEDICAL TECHNIQUE, INC.HMW2016-09-24
00815384021158OPTICS ONEMEDICAL TECHNIQUE, INC.HMW2016-09-24
00815384021189OPTICS ONEMEDICAL TECHNIQUE, INC.HMW2016-09-24
00815384021240OPTICS ONEMEDICAL TECHNIQUE, INC.HMW2016-09-24
00815384021271OPTICS ONEMEDICAL TECHNIQUE, INC.HMW2016-09-24
00815384021301OPTICS ONEMEDICAL TECHNIQUE, INC.HMW2016-09-24
00815384021332OPTICS ONEMEDICAL TECHNIQUE, INC.HMW2016-09-24
00815384021363OPTICS ONEMEDICAL TECHNIQUE, INC.HMW2016-09-24