PROGENIX™ PUTTY and PROGENIX™ PLUS

GUDID 00763000140502

DBM 000505 PROGENIX PUTTY .5CC

MEDTRONIC SOFAMOR DANEK, INC.

Bone matrix implant, human-derived
Primary Device ID00763000140502
NIH Device Record Key867bce40-dbb7-41f9-a097-3413180fce71
Commercial Distribution StatusIn Commercial Distribution
Brand NamePROGENIX™ PUTTY and PROGENIX™ PLUS
Version Model Number000505
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 Producttrue
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numbertrue
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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
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 Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *store at ambient temperature
Special Storage Condition, SpecifyBetween 0 and 0 *store at ambient temperature
Special Storage Condition, SpecifyBetween 0 and 0 *store at ambient temperature
Special Storage Condition, SpecifyBetween 0 and 0 *store at ambient temperature
Special Storage Condition, SpecifyBetween 0 and 0 *store at ambient temperature
Special Storage Condition, SpecifyBetween 0 and 0 *store at ambient temperature
Special Storage Condition, SpecifyBetween 0 and 0 *store at ambient temperature
Special Storage Condition, SpecifyBetween 0 and 0 *store at ambient temperature
Special Storage Condition, SpecifyBetween 0 and 0 *store at ambient temperature
Special Storage Condition, SpecifyBetween 0 and 0 *store at ambient temperature
Special Storage Condition, SpecifyBetween 0 and 0 *store at ambient temperature
Special Storage Condition, SpecifyBetween 0 and 0 *store at ambient temperature
Special Storage Condition, SpecifyBetween 0 and 0 *store at ambient temperature
Special Storage Condition, SpecifyBetween 0 and 0 *store at ambient temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000140502 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBPFiller, bone void, osteoinduction (w/o human growth factor)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-22
Device Publish Date2021-03-12

On-Brand Devices [PROGENIX™ PUTTY and PROGENIX™ PLUS]

00763000140571DBM 006010 PROGENIX PLUS PUTTY 10CC
00763000140564DBM 006005 PROGENIX PLUS PUTTY 5CC
00763000140557DBM 006002 PROGENIX PLUS PUTTY 2.5CC
00763000140540DBM 006001 PROGENIX PLUS PUTTY 1CC
00763000140533DBM 005110 PROGENIX PUTTY 10CC
00763000140526DBM 005005 PROGENIX PUTTY 5CC
00763000140519DBM 005001 PROGENIX PUTTY 1CC
00763000140502DBM 000505 PROGENIX PUTTY .5CC

Trademark Results [PROGENIX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PROGENIX
PROGENIX
98463197 not registered Live/Pending
Hunt, Christian
2024-03-22
PROGENIX
PROGENIX
87007945 not registered Dead/Abandoned
Concept Laboratories, Inc.
2016-04-20
PROGENIX
PROGENIX
78199350 not registered Dead/Abandoned
Medtronic, Inc.
2003-01-02
PROGENIX
PROGENIX
77081784 3373649 Live/Registered
Warsaw Orthopedic, Inc.
2007-01-12
PROGENIX
PROGENIX
75142407 not registered Dead/Abandoned
OSIRIS THERAPEUTICS, INC.
1996-07-30
PROGENIX
PROGENIX
74583361 not registered Dead/Abandoned
PROGENIX CORPORATION
1994-10-07

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.