SynVitro Hyadase

GUDID 20888937817960

SynVitro Hyadase. 5x1 ml

Origio A/S

IVF medium IVF medium
Primary Device ID20888937817960
NIH Device Record Key159e8dd6-d591-43d4-a9a6-d6b64ee54fe0
Commercial Distribution StatusIn Commercial Distribution
Brand NameSynVitro Hyadase
Version Model Number15115001D
Company DUNS305424269
Company NameOrigio A/S
Device Count5
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100888937817966 [Unit of Use]
GS120888937817960 [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 Number3
Public Version Date2018-07-06
Device Publish Date2016-07-22

On-Brand Devices [SynVitro Hyadase]

20888937817960SynVitro Hyadase. 5x1 ml
00888937833027SynVitro Hyadase. 5x1 ml

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