LensHooke X QC Video (For Semen) X QC Video

GUDID 04719874741044

BONRAYBIO CO., LTD.

Sperm concentration indicator IVD, control
Primary Device ID04719874741044
NIH Device Record Keyd099b882-5a88-4f6e-8601-cb21b2b62d52
Commercial Distribution StatusIn Commercial Distribution
Brand NameLensHooke X QC Video (For Semen)
Version Model NumberQXB V1 package
Catalog NumberX QC Video
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104719874741044 [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 Date2021-01-01
Device Publish Date2020-12-24

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

04719874741099QXB set package-US HT
04719874741082QXB set package-US BR
04719874741051QXB V2 package
04719874741044QXB V1 package
04719874741037QXB V0 package

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