MASTERGRAFT® Mini Granules

GUDID 00613994512802

MINIGRANULES 8600101 MASTERGRAFT 1CC

MEDTRONIC SOFAMOR DANEK, INC.

Bone matrix implant, synthetic
Primary Device ID00613994512802
NIH Device Record Key9b37de16-8ed2-42cd-ab01-4daa124916d3
Commercial Distribution StatusIn Commercial Distribution
Brand NameMASTERGRAFT® Mini Granules
Version Model Number8600101
Company DUNS830350380
Company NameMEDTRONIC SOFAMOR DANEK, 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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994512802 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LYCBone grafting material, synthetic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-12-19
Device Publish Date2018-11-18

On-Brand Devices [MASTERGRAFT® Mini Granules]

00613994512826MINIGRANULES 8600100 MASTERGRAFT 0.5CC
00613994512819MINIGRANULES 8600100INT MASTERGRAFT .5CC
00613994512802MINIGRANULES 8600101 MASTERGRAFT 1CC
00613994512796MINIGRANULES 8600101INT MASTERGRAFT 1CC
00613994512789MINIGRANULES 8600103 MASTERGRAFT 3CC
00613994512772MINIGRANULES 8600103INT MASTERGRAFT 3CC
00613994512765MINIGRANULES 8600105 MASTERGRAFT 5CC
00613994512758MINIGRANULES 8600105INT MASTERGRAFT 5CC

Trademark Results [MASTERGRAFT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MASTERGRAFT
MASTERGRAFT
78112930 2921419 Live/Registered
MEDTRONIC SOFAMOR DANEK USA, INC.
2002-03-06

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