ZipFix 03501080

GUDID H980035010800

APPLICATION INSTRUMENT FOR STERNAL ZIPFIX

SYNTHES (U.S.A.) LP

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• Primary Device ID: H980035010800
• NIH Device Record Key: f5f426c2-3bbb-498f-ab84-3a3eec272174
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZipFix
• Version Model Number: 03.501.080
• Catalog Number: 03501080
• Company DUNS: 832637081
• Company Name: SYNTHES (U.S.A.) LP
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	07611819418424 [Direct Marking]
GS1	10887587010847 [Primary]
HIBCC	H980035010800 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110789

FDA Product Code

• JDQ: CERCLAGE, FIXATION

Sterilization

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

[H980035010800]

Moist Heat or Steam Sterilization

[H980035010800]

Moist Heat or Steam Sterilization

[H980035010800]

Moist Heat or Steam Sterilization

[H980035010800]

Moist Heat or Steam Sterilization

[H980035010800]

Moist Heat or Steam Sterilization

[H980035010800]

Moist Heat or Steam Sterilization

[H980035010800]

Moist Heat or Steam Sterilization

[H980035010800]

Moist Heat or Steam Sterilization

[H980035010800]

Moist Heat or Steam Sterilization

[H980035010800]

Moist Heat or Steam Sterilization

[H980035010800]

Moist Heat or Steam Sterilization

[H980035010800]

Moist Heat or Steam Sterilization

[H980035010800]

Moist Heat or Steam Sterilization

[H980035010800]

Moist Heat or Steam Sterilization

[H980035010800]

Moist Heat or Steam Sterilization

[H980035010800]

Moist Heat or Steam Sterilization

[H980035010800]

Moist Heat or Steam Sterilization

[H980035010800]

Moist Heat or Steam Sterilization

[H980035010800]

Moist Heat or Steam Sterilization

[H980035010800]

Moist Heat or Steam Sterilization

[H980035010800]

Moist Heat or Steam Sterilization

[H980035010800]

Moist Heat or Steam Sterilization

[H980035010800]

Moist Heat or Steam Sterilization

[H980035010800]

Moist Heat or Steam Sterilization

[H980035010800]

Moist Heat or Steam Sterilization

[H980035010800]

Moist Heat or Steam Sterilization

[H980035010800]

Moist Heat or Steam Sterilization

[H980035010800]

Moist Heat or Steam Sterilization

[H980035010800]

Moist Heat or Steam Sterilization

[H980035010800]

Moist Heat or Steam Sterilization

[H980035010800]

Moist Heat or Steam Sterilization

[H980035010800]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-21
• Device Publish Date: 2015-09-14

On-Brand Devices [ZipFix]

• H9800850100120S0: STERNAL ZIPFIX WITH NEEDLE STERILE/20 PACK
• H9800850100105S0: STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK
• H9800850100101S0: STERNAL ZIPFIX WITH NEEDLE STERILE
• H980035010800: APPLICATION INSTRUMENT FOR STERNAL ZIPFIX