Needle, hypodermic, single lumen

GUDID 00858641006031

LIFE SCIENCE OUTSOURCING, INC.

Hypodermic needle, single-use
Primary Device ID00858641006031
NIH Device Record Key0bc0185a-72b3-40c0-81f1-e3001c6f0e34
Commercial Distribution Discontinuation2020-02-06
Commercial Distribution StatusNot in Commercial Distribution
Brand NameNeedle, hypodermic, single lumen
Version Model Number19B
Company DUNS017149456
Company NameLIFE SCIENCE OUTSOURCING, 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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100858641006031 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMINeedle, Hypodermic, Single Lumen

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number7
Public Version Date2020-02-07
Device Publish Date2016-05-03

Devices Manufactured by LIFE SCIENCE OUTSOURCING, INC.

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00858641006048 - Ser, administration, intravascular2020-02-10
00858641006055 - Set, i.V. Fluid Transfer2020-02-10
00858641006079 - Set, Administration, Intravascular2020-02-10
00858641006086 - Set, I.V. Fluid Transfer2020-02-10
00858641006093 - Set, Administration, Intravascular2020-02-10

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