FDA.reportPublic FDA data

Exact Medical Manufacturing, Inc.

Primary DI
00852205007922
Brand
Exact Medical Manufacturing, Inc.
Company
EXACT MEDICAL MANUFACTURING, INC.
Model
EP5513
Catalog number
EP5513
Device description
Microscope Drape, Leica 137x381cm – 54” x 150”
Published
2017-10-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
00852205007939PackageGS116Not in Commercial Distribution
00852205007946PackageGS11Not in Commercial Distribution
00852205007922PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852205007939008522050079398522050079390852205007939
00852205007946008522050079468522050079460852205007946
00852205007922008522050079228522050079220852205007922

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment/instrument drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
716-681-0866rdean@exactmm.com

Regulatory Flags#

DUNS number
014464314
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Donation ID number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975424199361Exact Medical Manufacturing, Inc.DEF5941DEF59412026-05-20
06975424199378Exact Medical Manufacturing, Inc.DEF5942DEF59422026-05-20
06975424199385Exact Medical Manufacturing, Inc.DEF5943DEF59432026-05-20
06975424199392Exact Medical Manufacturing, Inc.DEF5944DEF59442026-05-20
06975424199408Exact Medical Manufacturing, Inc.DEF5945DEF59452026-05-20
06975424199415Exact Medical Manufacturing, Inc.DEF5946DEF59462026-05-20
06975424199422Exact Medical Manufacturing, Inc.DEF5947DEF59472026-05-20
06975424199354Exact Medical Manufacturing, Inc.DEF5940DEF59402026-05-19
06975424199750Exact Medical Manufacturing, Inc.EN-RF-002EN-RF-0022026-05-19
06975424198722Proficient SurgicalPS20372026-03-11
06975424198739Proficient SurgicalPS89462026-03-11
16975424198729Proficient SurgicalPS20372026-03-11
16975424198736Proficient SurgicalPS89462026-03-11
06975424198838Exact Medical Manufacturing, Inc.VPS-G4SC-S1VPS-G4SC-S12026-03-09
06975424199279Exact Medical Manufacturing, Inc.E6997E69972026-03-09
26975424198832Exact Medical Manufacturing, Inc.VPS-G4SC-S1VPS-G4SC-S12026-03-09
16975424199276Exact Medical Manufacturing, Inc.E6997E69972026-03-09
06975424198449Exact Medical Manufacturing, Inc.TMPH-2000TMPH-20002025-11-19
06975424198456Exact Medical Manufacturing, Inc.TMPH-2002TMPH-20022025-11-19
06975424198463Exact Medical Manufacturing, Inc.PS-6000PS-60002025-11-19

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
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
00815384021035OPTICS 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