Arthrex BioExpress

GUDID 10815634020709

GD-1115-150 with 45 degree custom cannula

MICROMEDICS, INC.

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Primary Device ID10815634020709
NIH Device Record Key8da072ab-1016-43df-9276-f2837db05f36
Commercial Distribution StatusIn Commercial Distribution
Brand NameArthrex BioExpress
Version Model NumberABS-10053-15-4
Company DUNS066839630
Company NameMICROMEDICS, 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
GS100815634020702 [Primary]
GS110815634020709 [Package]
Contains: 00815634020702
Package: Inner Pack [5 Units]
In Commercial Distribution
GS120815634020706 [Package]
Package: Case [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMFSyringe, Piston

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-03
Device Publish Date2021-04-25

On-Brand Devices [Arthrex BioExpress]

10815634020709GD-1115-150 with 45 degree custom cannula
10815634020693GD-1115-100 with 45 degree custom cannula
10815634020686Graft Delivery Device
10815634020334Graft Delivery Device

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