MASTERGRAFT® Granules

GUDID 00721902168741

BIOLOGIC 7600110 85 BTCP 15 HA 10CC VIAL

MEDTRONIC SOFAMOR DANEK, INC.

Bone matrix implant, synthetic
Primary Device ID00721902168741
NIH Device Record Key79f1f8ca-7e94-4886-86db-3ccb85d2f337
Commercial Distribution StatusIn Commercial Distribution
Brand NameMASTERGRAFT® Granules
Version Model Number7600110
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
GS100721902168741 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQVFILLER, BONE VOID, CALCIUM COMPOUND

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-07-20

On-Brand Devices [MASTERGRAFT® Granules]

00721902184994BIOLOGIC 7600130 85 BTCP 15 HA 30CC VIAL
00721902184987BIOLOGIC 7600115 85 BTCP 15 HA 15CC VIAL
00721902168741BIOLOGIC 7600110 85 BTCP 15 HA 10CC VIAL
00721902168734BIOLOGIC 7600105 85 BTCP 15 HA 5CC VIAL

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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