04315413

GUDID H980043154130

2.0MM CLOVERLEAF FOOT C-TYPE FOR CMF DISTRACTOR

SYNTHES (U.S.A.) LP

Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor

• Primary Device ID: H980043154130
• NIH Device Record Key: f631d9ee-ea4a-4e13-bfdd-103ffe8c0830
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 04.315.413
• Catalog Number: 04315413
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10887587016184 [Primary]
HIBCC	H980043154130 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060138

FDA Product Code

• MQN: EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR

Sterilization

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

[H980043154130]

Moist Heat or Steam Sterilization

[H980043154130]

Moist Heat or Steam Sterilization

[H980043154130]

Moist Heat or Steam Sterilization

[H980043154130]

Moist Heat or Steam Sterilization

[H980043154130]

Moist Heat or Steam Sterilization

[H980043154130]

Moist Heat or Steam Sterilization

[H980043154130]

Moist Heat or Steam Sterilization

[H980043154130]

Moist Heat or Steam Sterilization

[H980043154130]

Moist Heat or Steam Sterilization

[H980043154130]

Moist Heat or Steam Sterilization

[H980043154130]

Moist Heat or Steam Sterilization

[H980043154130]

Moist Heat or Steam Sterilization

[H980043154130]

Moist Heat or Steam Sterilization

[H980043154130]

Moist Heat or Steam Sterilization

[H980043154130]

Moist Heat or Steam Sterilization

[H980043154130]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-12-13
• Device Publish Date: 2015-09-14

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• H981042006160 - Axon: 2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 32MM THREAD LENGTH
• H981042006170 - Axon: 2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 34MM THREAD LENGTH
• H981042006180 - Axon: 2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 36MM THREAD LENGTH
• H981042006190 - Axon: 2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 38MM THREAD LENGTH