OSIS Medical OS8033652

GUDID 16975424195575

OSIS DRAPE - LEICA MICROSCOPE - MINI - 46"X80"

EXACT MEDICAL MANUFACTURING, INC.

Medical equipment drape, single-use
Primary Device ID16975424195575
NIH Device Record Key45208a18-2738-4e4e-ae58-82f7e0b456e5
Commercial Distribution StatusIn Commercial Distribution
Brand NameOSIS Medical
Version Model NumberOS8033652
Catalog NumberOS8033652
Company DUNS014464314
Company NameEXACT MEDICAL MANUFACTURING, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106975424195578 [Primary]
GS116975424195575 [Package]
Contains: 06975424195578
Package: Inner Case [10 Units]
In Commercial Distribution
GS126975424195572 [Package]
Package: Case [1 Units]
In Commercial Distribution

FDA Product Code

KKXDrape, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-04
Device Publish Date2024-06-26

On-Brand Devices [OSIS Medical]

16975424195575OSIS DRAPE - LEICA MICROSCOPE - MINI - 46"X80"
16975424195568OSIS DRAPE - LEICA MICROSCOPE - MEDIUM - 46"X120"
16975424195551OSIS DRAPE - LEICA MICROSCOPE - LARGE - 54"X150"
26975424195541OSIS DRAPE - LEICA MICROSCOPE - HANDLES - 5"X10"

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