395782

GUDID H6793957820

8.0MM CARBON FIBER ROD 200MM

Synthes GmbH

External orthopaedic fixation system reprocessed component

• Primary Device ID: H6793957820
• NIH Device Record Key: 9ec143ac-326a-4c26-a034-7076b686515b
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 395.782
• Catalog Number: 395782
• Company DUNS: 486711679
• Company Name: Synthes GmbH
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07611819093621 [Direct Marking]
GS1	10886982200747 [Primary]
HIBCC	H6793957820 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011034

FDA Product Code

• LXT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE

Sterilization

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

[H6793957820]

Moist Heat or Steam Sterilization

[H6793957820]

Moist Heat or Steam Sterilization

[H6793957820]

Moist Heat or Steam Sterilization

[H6793957820]

Moist Heat or Steam Sterilization

[H6793957820]

Moist Heat or Steam Sterilization

[H6793957820]

Moist Heat or Steam Sterilization

[H6793957820]

Moist Heat or Steam Sterilization

[H6793957820]

Moist Heat or Steam Sterilization

[H6793957820]

Moist Heat or Steam Sterilization

[H6793957820]

Moist Heat or Steam Sterilization

[H6793957820]

Moist Heat or Steam Sterilization

[H6793957820]

Moist Heat or Steam Sterilization

[H6793957820]

Moist Heat or Steam Sterilization

[H6793957820]

Moist Heat or Steam Sterilization

[H6793957820]

Moist Heat or Steam Sterilization

[H6793957820]

Moist Heat or Steam Sterilization

[H6793957820]

Moist Heat or Steam Sterilization

[H6793957820]

Moist Heat or Steam Sterilization

[H6793957820]

Moist Heat or Steam Sterilization

[H6793957820]

Moist Heat or Steam Sterilization

[H6793957820]

Moist Heat or Steam Sterilization

[H6793957820]

Moist Heat or Steam Sterilization

[H6793957820]

Moist Heat or Steam Sterilization

[H6793957820]

Moist Heat or Steam Sterilization

[H6793957820]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-05-02
• Device Publish Date: 2015-09-14

Devices Manufactured by Synthes GmbH

• 10886982347565 - NA: 2024-09-16 4.5 DRILL GUIDE
• 10886982346902 - NA: 2024-09-09 GUIDE WIRE Ø0.8 LENGTH 100MM DOUBLE TIP
• 10886982346919 - NA: 2024-09-09 GUIDE WIRE Ø1.1 LENGTH 150MM DOUBLE TIP
• 10886982346926 - NA: 2024-09-09 GUIDE WIRE Ø1.4 LENGTH 150MM DOUBLE TIP
• 10887587077055 - NA: 2024-08-29 MATRIXSTERNUM STRAIGHT PLATE 4 HOLES
• 10887587077062 - NA: 2024-08-29 MATRIXSTERNUM STRAIGHT PLATE 6 HOLES
• 10887587077079 - NA: 2024-08-29 MATRIXSTERNUM T-PLATE 7 HOLES
• 10887587077086 - NA: 2024-08-29 MATRIXSTERNUM X-PLATE SMALL/8 HOLES