ORIGIO Gradient 40/80

GUDID 60888937816879

ORIGIO Gradient 40/80, 2x10 ml

Origio A/S

IVF medium kit IVF medium kit
Primary Device ID60888937816879
NIH Device Record Key0eae00c0-f99d-4b87-bffc-8620ccb39907
Commercial Distribution StatusIn Commercial Distribution
Brand NameORIGIO Gradient 40/80
Version Model Number84022010D
Company DUNS305424269
Company NameOrigio A/S
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

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
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from light

Device Identifiers

Device Issuing AgencyDevice ID
GS160888937816879 [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 StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-04-18

On-Brand Devices [ORIGIO Gradient 40/80]

60888937816886ORIGIO Gradient 40/80, 2x60 ml
60888937816879ORIGIO Gradient 40/80, 2x10 ml
60888937816862ORIGIO Gradient 40/80 12 x 10 ml

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