SAGE 1-Step

GUDID 00888937803365

SAGE 1-Step with HSA and phenol red. 60 ml

Origio A/S

IVF medium
Primary Device ID00888937803365
NIH Device Record Key4525fd1b-0752-47d1-8aa5-aa5c55bcb56b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSAGE 1-Step
Version Model Number67010060D
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 Kitfalse
Device Combination Producttrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100888937803365 [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 [SAGE 1-Step]

00888937833072SAGE 1-Step GM-CSF with SPS. 3 ml.
00888937833058Sage 1-Step GM-CSF with HSA. 3 ml
00888937803402SAGE 1-Step with SPS and phenol red
00888937803389SAGE 1-Step with SPS and phenol red. 10 ml
00888937803365SAGE 1-Step with HSA and phenol red. 60 ml
00888937803341SAGE 1-Step with Human Serum Albumin. 10 ml

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