04315127

GUDID H980043151270

REMOVABLE EXTENSION ARM-FLEX 40MM FOR CMF DISTRACTOR

SYNTHES (U.S.A.) LP

Craniofacial bone distractor extension Craniofacial bone distractor extension Craniofacial bone distractor extension Craniofacial bone distractor extension Craniofacial bone distractor extension Craniofacial bone distractor extension Craniofacial bone distractor extension Craniofacial bone distractor extension Craniofacial bone distractor extension Craniofacial bone distractor extension Craniofacial bone distractor extension Craniofacial bone distractor extension Craniofacial bone distractor extension Craniofacial bone distractor extension Craniofacial bone distractor extension Craniofacial bone distractor extension

• Primary Device ID: H980043151270
• NIH Device Record Key: ac41ef17-1b16-4983-b846-b23dcfac3997
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 04.315.127
• Catalog Number: 04315127
• 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	10887587015675 [Primary]
HIBCC	H980043151270 [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

[H980043151270]

Moist Heat or Steam Sterilization

[H980043151270]

Moist Heat or Steam Sterilization

[H980043151270]

Moist Heat or Steam Sterilization

[H980043151270]

Moist Heat or Steam Sterilization

[H980043151270]

Moist Heat or Steam Sterilization

[H980043151270]

Moist Heat or Steam Sterilization

[H980043151270]

Moist Heat or Steam Sterilization

[H980043151270]

Moist Heat or Steam Sterilization

[H980043151270]

Moist Heat or Steam Sterilization

[H980043151270]

Moist Heat or Steam Sterilization

[H980043151270]

Moist Heat or Steam Sterilization

[H980043151270]

Moist Heat or Steam Sterilization

[H980043151270]

Moist Heat or Steam Sterilization

[H980043151270]

Moist Heat or Steam Sterilization

[H980043151270]

Moist Heat or Steam Sterilization

[H980043151270]

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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• 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