DePuy Songer Spinal Cable System 7925015

GUDID 10846468005211

Crimp, Flange, Ti 2-Pack, NS, AcroMed

Pioneer Surgical Technology, Inc.

Internal spinal fixation system cable, sterile

• Primary Device ID: 10846468005211
• NIH Device Record Key: 15eeca5a-0c44-43f6-9fcd-0ce05eba9027
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DePuy Songer Spinal Cable System
• Version Model Number: 400-204
• Catalog Number: 7925015
• Company DUNS: 793384496
• Company Name: Pioneer Surgical Technology, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(386)418-8888
• Email: labelrequest@resolvesurg.com
• Phone: +1(386)418-8888
• Email: labelrequest@resolvesurg.com
• Phone: +1(386)418-8888
• Email: labelrequest@resolvesurg.com
• Phone: +1(386)418-8888
• Email: labelrequest@resolvesurg.com
• Phone: +1(386)418-8888
• Email: labelrequest@resolvesurg.com
• Phone: +1(386)418-8888
• Email: labelrequest@resolvesurg.com
• Phone: +1(386)418-8888
• Email: labelrequest@resolvesurg.com
• Phone: +1(386)418-8888
• Email: labelrequest@resolvesurg.com
• Phone: +1(386)418-8888
• Email: labelrequest@resolvesurg.com
• Phone: +1(386)418-8888
• Email: labelrequest@resolvesurg.com
• Phone: +1(386)418-8888
• Email: labelrequest@resolvesurg.com
• Phone: +1(386)418-8888
• Email: labelrequest@resolvesurg.com
• Phone: +1(386)418-8888
• Email: labelrequest@resolvesurg.com
• Phone: +1(386)418-8888
• Email: labelrequest@resolvesurg.com
• Phone: +1(386)418-8888
• Email: labelrequest@resolvesurg.com
• Phone: +1(386)418-8888
• Email: labelrequest@resolvesurg.com
• Phone: +1(386)418-8888
• Email: labelrequest@resolvesurg.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840298704484 [Primary]
GS1	10846468005211 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K935481
• Premarket Notification: K941213

FDA Product Code

• JDQ: CERCLAGE, FIXATION

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[10846468005211]

Moist Heat or Steam Sterilization

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[10846468005211]

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[10846468005211]

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[10846468005211]

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[10846468005211]

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[10846468005211]

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[10846468005211]

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[10846468005211]

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[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

[10846468005211]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-10-14
• Device Publish Date: 2015-12-10

On-Brand Devices [DePuy Songer Spinal Cable System]

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