SpermGrad

GUDID 07350025910369

Vitrolife Sweden AB

IVF medium
Primary Device ID07350025910369
NIH Device Record Keyca7d42c7-5143-4733-bdc1-4fef3a049294
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpermGrad
Version Model Number10099
Company DUNS631805488
Company NameVitrolife Sweden AB
Device Count1
DM Exemptfalse
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107350025910369 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQLMedia, Reproductive

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-01-24
Device Publish Date2016-09-13

On-Brand Devices [SpermGrad]

0735002591489310338
0735002591488610238
0735002591487910339
0735002591486210239
0735002591036910099
0735002591035210102
1735002591479110139
1735002591478410138

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.