04045870S

GUDID 10886982296054

END CAP FOR TFNA / 0MM STERILE

SYNTHES (U.S.A.) LP

Bone nail end-cap, sterile

• Primary Device ID: 10886982296054
• NIH Device Record Key: 96ac632b-d388-46ca-bd3a-a8e829b62c55
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 04.045.870S
• Catalog Number: 04045870S
• 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: 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

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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886982296054 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160167

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-24
• Device Publish Date: 2020-12-16

Devices Manufactured by SYNTHES (U.S.A.) LP

• H9812982060 - NA: 2024-07-24 ANGLED LAMINA HOOK/ DUAL-OPENING SIDE
• H6792042280 - NA: 2024-07-24 3.5MM SHAFT SCREW 28MM
• H6792042320 - NA: 2024-07-24 3.5MM SHAFT SCREW 32MM
• H6792042340 - NA: 2024-07-24 3.5MM SHAFT SCREW 34MM
• H6792042360 - NA: 2024-07-24 3.5MM SHAFT SCREW 36MM
• H6792042380 - NA: 2024-07-24 3.5MM SHAFT SCREW 38MM
• H6792042400 - NA: 2024-07-24 3.5MM SHAFT SCREW 40MM
• H6794042160 - NA: 2024-07-24 3.5MM TI SHAFT SCREW 16MM