FDA.reportPublic FDA data

Exact Medical Manufacturing, Inc.

Primary DI
00852205007892
Brand
Exact Medical Manufacturing, Inc.
Company
EXACT MEDICAL MANUFACTURING, INC.
Model
EP5512
Catalog number
EP5512
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
00852205007908PackageGS110Not in Commercial Distribution
00852205007915PackageGS11Not in Commercial Distribution
00852205007892PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852205007908008522050079088522050079080852205007908
00852205007915008522050079158522050079150852205007915
00852205007892008522050078928522050078920852205007892

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
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
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
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