ZipFix 0850100101S

GUDID H9800850100101S0

STERNAL ZIPFIX WITH NEEDLE STERILE

SYNTHES (U.S.A.) LP

Sternal fixation device

• Primary Device ID: H9800850100101S0
• NIH Device Record Key: 1b1846ae-d0e3-486a-93df-4a2644815c68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZipFix
• Version Model Number: 08.501.001.01S
• Catalog Number: 0850100101S
• Company DUNS: 832637081
• Company Name: SYNTHES (U.S.A.) LP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10887587025971 [Primary]
HIBCC	H9800850100101S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110789

FDA Product Code

• JDQ: CERCLAGE, FIXATION

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• 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