Embryo Thawing Pack

GUDID 60888937801301

Embryo Thawing Pack. 4x10 ml

Origio A/S

IVF medium kit IVF medium kit
Primary Device ID60888937801301
NIH Device Record Keyb9ed1562-3631-477a-a8e9-ee44d40d4e8f
Commercial Distribution StatusIn Commercial Distribution
Brand NameEmbryo Thawing Pack
Version Model Number10984010D
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 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
GS160888937801301 [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 Date2017-03-28

On-Brand Devices [Embryo Thawing Pack]

60888937816268Embryo Thawing Pack. 4x2 ml
60888937801301Embryo Thawing Pack. 4x10 ml

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