N/A

GUDID 20888937902017

ICSI MICROPIPETS

ORIGIO INC.

Assisted reproduction microtool
Primary Device ID20888937902017
NIH Device Record Key812a7b18-648f-4074-9402-4f98e570df82
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberMIC-35-25
Company DUNS787068394
Company NameORIGIO INC.
Device Count1
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS120888937902017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQHMicrotools, Assisted Reproduction (Pipettes)

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 Date2016-08-22

On-Brand Devices [N/A]

60888937907805O-RING KIT WITH COLLET
60888937907799O-RING KIT WITH COLLET
60888937900028SEMEN ANALYSIS KIT
60888937900011SEMEN ANALYSIS KIT
20888937911576BIOPSY MICROPIPETS
20888937911569BIOPSY MICROPIPETS
20888937911033COUNTING CHAMBER
20888937910807ICSI MICROPIPETS
20888937910784BIOPSY MICROPIPETS
20888937910777HOLDING MICROPIPETS
20888937910760ICSI MICROPIPETS
20888937907814PLUNGER REPLACEMENT
20888937907777N/A
20888937907685PZD MICROPIPETS
20888937907661PZD MICROPIPETS
20888937907609PZD MICROPIPETS
20888937907548PZD MICROPIPETS
20888937907531PZD MICROPIPETS
20888937907517PZD MICROPIPETS
20888937907500PZD MICROPIPETS
20888937907487PZD MICROPIPETS
20888937907463PZD MICROPIPETS
20888937905391HOLDING MICROPIPETS
20888937905377HOLDING MICROPIPETS
20888937905353HOLDING MICROPIPETS
20888937905308HOLDING MICROPIPETS
20888937905292HOLDING MICROPIPETS
20888937905278HOLDING MICROPIPETS
20888937905230HOLDING MICROPIPETS
20888937905216HOLDING MICROPIPETS
20888937905193HOLDING MICROPIPETS
20888937905186HOLDING MICROPIPETS
20888937905155HOLDING MICROPIPETS
20888937905131HOLDING MICROPIPETS
20888937905117HOLDING MICROPIPETS
20888937905094HOLDING MICROPIPETS
20888937905087HOLDING MICROPIPETS
20888937905056HOLDING MICROPIPETS
20888937905032HOLDING MICROPIPETS
20888937905018HOLDING MICROPIPETS
20888937904998HOLDING MICROPIPETS
20888937904981HOLDING MICROPIPETS
20888937904967HOLDING MICROPIPETS
20888937904929HOLDING MICROPIPETS
20888937904912HOLDING MICROPIPETS
20888937904882HOLDING MICROPIPETS
20888937904868HOLDING MICROPIPETS
20888937904851HOLDING MICROPIPETS
20888937904837HOLDING MICROPIPETS
20888937904806HOLDING MICROPIPETS

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