Graft Delivery, DePuy Synthes

GUDID 20815634020621

Graft Delivery, DePuy Synthes

MICROMEDICS, INC.

Bone graft delivery kit
Primary Device ID20815634020621
NIH Device Record Key174bf360-cfc9-4071-8833-608c2a34262c
Commercial Distribution StatusIn Commercial Distribution
Brand NameGraft Delivery, DePuy Synthes
Version Model Number03-950-001S
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
GS100815634020627 [Primary]
GS110815634020624 [Package]
Contains: 00815634020627
Package: Shelf Box [5 Units]
In Commercial Distribution
GS120815634020621 [Package]
Contains: 10815634020624
Package: Ship Box [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 Date2018-07-16
Device Publish Date2018-06-15

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