04500241

GUDID H980045002410

1.3MM CURVILINEAR DISTRACTOR R40/LEFT

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: H980045002410
• NIH Device Record Key: 1f742659-7651-4411-888d-ec46e835acae
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 04.500.241
• Catalog Number: 04500241
• 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	10887587016870 [Primary]
HIBCC	H980045002410 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121502

FDA Product Code

• MQN: EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR

Sterilization

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

[H980045002410]

Moist Heat or Steam Sterilization

[H980045002410]

Moist Heat or Steam Sterilization

[H980045002410]

Moist Heat or Steam Sterilization

[H980045002410]

Moist Heat or Steam Sterilization

[H980045002410]

Moist Heat or Steam Sterilization

[H980045002410]

Moist Heat or Steam Sterilization

[H980045002410]

Moist Heat or Steam Sterilization

[H980045002410]

Moist Heat or Steam Sterilization

[H980045002410]

Moist Heat or Steam Sterilization

[H980045002410]

Moist Heat or Steam Sterilization

[H980045002410]

Moist Heat or Steam Sterilization

[H980045002410]

Moist Heat or Steam Sterilization

[H980045002410]

Moist Heat or Steam Sterilization

[H980045002410]

Moist Heat or Steam Sterilization

[H980045002410]

Moist Heat or Steam Sterilization

[H980045002410]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-09-23
• Device Publish Date: 2015-09-14

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• H679022221220 - NA: 2024-02-27 5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/22MM
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• H679022221260 - NA: 2024-02-27 5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/26MM