Injection Spike

GUDID 10816203021646

DMSO-Resistant Bag Spike with needle injection port , bulk packed

ORIGEN BIOMEDICAL, INC.

Blood transfer set
Primary Device ID10816203021646
NIH Device Record Key409ee44a-f2fe-47b1-93dc-04140ec48243
Commercial Distribution Discontinuation2024-12-11
Commercial Distribution StatusNot in Commercial Distribution
Brand NameInjection Spike
Version Model NumberIBS-B
Company DUNS625272232
Company NameORIGEN BIOMEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110816203021646 [Primary]
GS120816203021643 [Package]
Package: Case [50 Units]
Discontinued: 2024-12-11
Not in Commercial Distribution

FDA Product Code

KJGTube, Tissue Culture

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2024-12-12
Device Publish Date2016-09-23

On-Brand Devices [Injection Spike]

10816203021646DMSO-Resistant Bag Spike with needle injection port , bulk packed
10816203020113DMSO-Resistant Bag Spike with non- ahdered needle injection port, case of 50

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