LensHooke X QC Reticle (For Semen) X QC Reticle

GUDID 04719874740894

BONRAYBIO CO., LTD.

Sperm concentration indicator IVD, control
Primary Device ID04719874740894
NIH Device Record Key57f0ab48-e142-41c4-bc96-fceed8962b73
Commercial Distribution StatusIn Commercial Distribution
Brand NameLensHooke X QC Reticle (For Semen)
Version Model NumberX QC Reticle - L1_BR USA CORP.
Catalog NumberX QC Reticle
Company DUNS658872369
Company NameBONRAYBIO CO., LTD.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104719874740894 [Primary]

FDA Product Code

NRFMaterial, Quality Control, Semen Analysis

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-24
Device Publish Date2020-03-16

On-Brand Devices [LensHooke X QC Reticle (For Semen)]

04719874740900X QC Reticle - L2_BR USA CORP.
04719874740894X QC Reticle - L1_BR USA CORP.
04719874740887X QC Reticle - L0_BR USA CORP.
0471987474087004719874740887 LensHooke X QC Reticle (For Semen)-L0 04719874740894 LensHooke X QC Reticle (For
04719874740863X QC Reticle - L2_US
04719874740856X QC Reticle - L1_US
04719874740849X QC Reticle - L0_US
0471987474083204719874740849 LensHooke X QC Reticle (For Semen)- L0 04719874740856 LensHooke X QC Reticle (For

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