FDA.reportPublic FDA data

Exact Medical Manufacturing, Inc.

Primary DI
00850003355948
Brand
Exact Medical Manufacturing, Inc.
Company
EXACT MEDICAL MANUFACTURING, INC.
Model
OH-3
Catalog number
OH-3
Device description
Face Shield, Attached with Full Head Covering
Published
2019-12-02
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

Product Codes#

Code, Name table
CodeName
LYUAccessory, Surgical Apparel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYUAccessory, Surgical ApparelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850003355955PackageGS125Not in Commercial Distribution
00850003355948PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850003355955008500033559558500033559550850003355955
00850003355948008500033559488500033559480850003355948

GMDN Terms#

Term, Definition table
TermDefinition
Face splash shield, single-useA clear, transparent guard intended to provide full face cover, to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure. It is commonly known as a splash shield. This is a single-use device.

Regulatory Flags#

DUNS number
014464314
Device count
1
DM exempt
true
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

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00810219420083American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00850073571996American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00810219420090American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
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