Sperm Preparation Medium

GUDID 20888937800856

Sperm Preparation Medium. 2x10 ml

Origio A/S

IVF medium IVF medium
Primary Device ID20888937800856
NIH Device Record Key5ef7c67f-da56-4385-94e6-1d6ebdd04ffd
Commercial Distribution StatusIn Commercial Distribution
Brand NameSperm Preparation Medium
Version Model Number10702010D
Company DUNS305424269
Company NameOrigio A/S
Device Count2
DM Exemptfalse
Pre-market Exemptfalse
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 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
GS100888937817447 [Unit of Use]
GS120888937800856 [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 [Sperm Preparation Medium]

20888937829390Sperm Preparation Medium with phenol red. 10x10 ml
20888937817403Sperm Preparation Medium without phenol red. 10x10 ml
20888937800856Sperm Preparation Medium. 2x10 ml
00888937800791Sperm Preparation Medium with phenol red. 60 ml
00888937800708Sperm Preparation Medium without phenol red. 60 ml

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