Apheresis Needle with MASTERGUARD Protector 4R2441

GUDID 10811137012418

Apheresis Needle with MASTERGUARD Protector 17 Ga. x 1-1/4'' BE. Sterile Fluid Path.

FENWAL, INC.

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Primary Device ID10811137012418
NIH Device Record Keyeaa80718-d45e-4b12-8d05-7e978ec15222
Commercial Distribution StatusIn Commercial Distribution
Brand NameApheresis Needle with MASTERGUARD Protector
Version Model Number4R2441
Catalog Number4R2441
Company DUNS794519020
Company NameFENWAL, 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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100811137012411 [Primary]
GS110811137012418 [Package]
Contains: 00811137012411
Package: Case [250 Units]
In Commercial Distribution

FDA Product Code

FIENeedle, Fistula

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-02

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