395781

GUDID H6793957810

PROTECTIVE CAPS FOR 8.0MM CARBON FIBER ROD

SYNTHES (U.S.A.) LP

External orthopaedic fixation system reprocessed component External orthopaedic fixation system reprocessed component External orthopaedic fixation system reprocessed component External orthopaedic fixation system reprocessed component External orthopaedic fixation system reprocessed component External orthopaedic fixation system reprocessed component External orthopaedic fixation system reprocessed component External orthopaedic fixation system reprocessed component External orthopaedic fixation system reprocessed component External orthopaedic fixation system reprocessed component External orthopaedic fixation system reprocessed component External orthopaedic fixation system reprocessed component External orthopaedic fixation system reprocessed component External orthopaedic fixation system reprocessed component External orthopaedic fixation system reprocessed component External orthopaedic fixation system reprocessed component External orthopaedic fixation system reprocessed component

• Primary Device ID: H6793957810
• NIH Device Record Key: 7082eb7a-8fe6-4649-bd3c-21ac48dc6ff4
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 395.781
• Catalog Number: 395781
• Company DUNS: 832637081
• Company Name: SYNTHES (U.S.A.) LP
• Device Count: 2
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	20886982200720 [Primary]
GS1	80886982200722 [Unit of Use]
HIBCC	H6793957810 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090658

FDA Product Code

• KTT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

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

[H6793957810]

Moist Heat or Steam Sterilization

[H6793957810]

Moist Heat or Steam Sterilization

[H6793957810]

Moist Heat or Steam Sterilization

[H6793957810]

Moist Heat or Steam Sterilization

[H6793957810]

Moist Heat or Steam Sterilization

[H6793957810]

Moist Heat or Steam Sterilization

[H6793957810]

Moist Heat or Steam Sterilization

[H6793957810]

Moist Heat or Steam Sterilization

[H6793957810]

Moist Heat or Steam Sterilization

[H6793957810]

Moist Heat or Steam Sterilization

[H6793957810]

Moist Heat or Steam Sterilization

[H6793957810]

Moist Heat or Steam Sterilization

[H6793957810]

Moist Heat or Steam Sterilization

[H6793957810]

Moist Heat or Steam Sterilization

[H6793957810]

Moist Heat or Steam Sterilization

[H6793957810]

Moist Heat or Steam Sterilization

[H6793957810]

Moist Heat or Steam Sterilization

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

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• H679022221160 - NA: 2024-02-27 5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/16MM
• H679022221180 - NA: 2024-02-27 5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/18MM
• H679022221200 - NA: 2024-02-27 5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/20MM
• H679022221220 - NA: 2024-02-27 5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/22MM
• H679022221240 - NA: 2024-02-27 5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/24MM
• H679022221260 - NA: 2024-02-27 5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/26MM