DePuy Songer Spinal Cable System 7825016S

GUDID 10846468005082

Bar, Round, SS 2-Pack, Strl, AcroMed

Pioneer Surgical Technology, Inc.

Internal spinal fixation system cable, sterile
Primary Device ID10846468005082
NIH Device Record Key85fb7014-1ec3-40ef-91d3-3589f2a5c2df
Commercial Distribution StatusIn Commercial Distribution
Brand NameDePuy Songer Spinal Cable System
Version Model Number400-107
Catalog Number7825016S
Company DUNS793384496
Company NamePioneer Surgical Technology, 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

Customer Support Contacts

Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(386)418-8888
Emaillabelrequest@resolvesurg.com
Phone+1(386)418-8888
Emaillabelrequest@resolvesurg.com
Phone+1(386)418-8888
Emaillabelrequest@resolvesurg.com
Phone+1(386)418-8888
Emaillabelrequest@resolvesurg.com
Phone+1(386)418-8888
Emaillabelrequest@resolvesurg.com
Phone+1(386)418-8888
Emaillabelrequest@resolvesurg.com
Phone+1(386)418-8888
Emaillabelrequest@resolvesurg.com
Phone+1(386)418-8888
Emaillabelrequest@resolvesurg.com
Phone+1(386)418-8888
Emaillabelrequest@resolvesurg.com
Phone+1(386)418-8888
Emaillabelrequest@resolvesurg.com
Phone+1(386)418-8888
Emaillabelrequest@resolvesurg.com
Phone+1(386)418-8888
Emaillabelrequest@resolvesurg.com
Phone+1(386)418-8888
Emaillabelrequest@resolvesurg.com
Phone+1(386)418-8888
Emaillabelrequest@resolvesurg.com
Phone+1(386)418-8888
Emaillabelrequest@resolvesurg.com
Phone+1(386)418-8888
Emaillabelrequest@resolvesurg.com
Phone+1(386)418-8888
Emaillabelrequest@resolvesurg.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100840298704453 [Primary]
GS110846468005082 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDQCERCLAGE, FIXATION

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

[10846468005082]

Radiation Sterilization

[10846468005082]

Radiation Sterilization

[10846468005082]

Radiation Sterilization

[10846468005082]

Radiation Sterilization

[10846468005082]

Radiation Sterilization

[10846468005082]

Radiation Sterilization

[10846468005082]

Radiation Sterilization

[10846468005082]

Radiation Sterilization

[10846468005082]

Radiation Sterilization

[10846468005082]

Radiation Sterilization

[10846468005082]

Radiation Sterilization

[10846468005082]

Radiation Sterilization

[10846468005082]

Radiation Sterilization

[10846468005082]

Radiation Sterilization

[10846468005082]

Radiation Sterilization

[10846468005082]

Radiation Sterilization

[10846468005082]

Radiation Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-10-14
Device Publish Date2015-12-10

On-Brand Devices [DePuy Songer Spinal Cable System]

10846468074743Cable, Single, Ti W/Cmp&Br, 12-Pk,NS, AM
10846468005365Bar, Flex, Large, Ti, NS, AcroMed
10846468005358Bar, Flex, Small, Ti, NS, AcroMed
10846468005341Bar, Flex, Large, Ti, Strl, AcroMed
10846468005334Bar, Flex, Small, Ti, Strl, AcroMed
10846468005310Cable, Double,Loop,Ti W/Cmp,12-Pk,NS,AM
10846468005303Cable, Single,Ti W/Cmp&Br,12-Pk, Strl,AM
10846468005297Cable, Dbl, Loop,Ti W/Cmp 12-Pk, Strl,
10846468005280Cable, ISOLA, Ti, W/Crmp 6-Pack, Strl,
10846468005273Cable, ISOLA,Ti,W/Crmp 6-Pack,NS,AcroMed
10846468005266Bar, Flat, Ti 2-Pk, Strl, AcroMed STS
10846468005259Bar, Flat, Ti 2-Pack, NS, AcroMed
10846468005242Bar, Round, Ti 2-Pack, Strl, AcroMed STS
10846468005235Bar, Round, Ti 2-Pack, NS, AcroMed
10846468005228Crimp, Flange,Ti 2-Pk, Strl, AcroMed STS
10846468005211Crimp, Flange, Ti 2-Pack, NS, AcroMed
10846468005204Cable, Single, Ti STS W/Crmp&Bar, Strl
10846468005198Cable, Single, Ti W/Crmp&Bar, NS,AcroMed
10846468005181Cable, Dbl,Loop,Ti W/Crmp, Strl, AcroMed
10846468005174Cable, Dbl,Loop,TI W/Crmp,NS,AcroMed STS
10846468005167Cable, Single, SS w/Crimp &Bar,12-Pk,NS,
10846468005150Cable, Double, Loop, SS W/Cmp, 12-Pk,NS,
10846468005143Cable,Single,SS,W/Crmp &Br, 12-Pk, Strl
10846468005136Cable, Dbl, Loop,SS W/Cmp 12-Pk, Strl
10846468005129Cable, ISOLA, SS, W/Crmp 6-Pack, Strl
10846468005112Cable, ISOLA,SS,W/Crmp 6-Pack,NS,AcroMed
10846468005105Bar, Flat, SS 2-Pack, Strl, AcroMed
10846468005099Bar, Flat, SS 2-Pack, NS, AcroMed
10846468005082Bar, Round, SS 2-Pack, Strl, AcroMed
10846468005075Bar, Round, SS 2-Pack, NS, AcroMed
10846468005068Crimp, Flange, SS 2-Pack, Strl, AcroMed
10846468005051Crimp, Flange, SS 2-Pack, NS, AcroMed
10846468005044Cable, Single,SS STS w/Crmp&Bar,Strl,Acro
10846468005037Cable, Single, SS W/Crmp&Bar, NS,AcroMed
10846468005020Cable, Double, Loop, SS, W/Crmp, Strl,
10846468005013Cable, Double, Loop, SS, w/Crmp, NS,
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