04315322

GUDID H980043153220

1.5MM ELV MESH FOOT B-TYPE 7.5MM OFFSET

SYNTHES (U.S.A.) LP

Implantable craniofacial bone distractor

• Primary Device ID: H980043153220
• NIH Device Record Key: aeaf6b60-a7f5-49d0-b7cc-17c2d8aa2056
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 04.315.322
• Catalog Number: 04315322
• 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	10887587015897 [Primary]
HIBCC	H980043153220 [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

[H980043153220]

Moist Heat or Steam Sterilization

[H980043153220]

Moist Heat or Steam Sterilization

[H980043153220]

Moist Heat or Steam Sterilization

[H980043153220]

Moist Heat or Steam Sterilization

[H980043153220]

Moist Heat or Steam Sterilization

[H980043153220]

Moist Heat or Steam Sterilization

[H980043153220]

Moist Heat or Steam Sterilization

[H980043153220]

Moist Heat or Steam Sterilization

[H980043153220]

Moist Heat or Steam Sterilization

[H980043153220]

Moist Heat or Steam Sterilization

[H980043153220]

Moist Heat or Steam Sterilization

[H980043153220]

Moist Heat or Steam Sterilization

[H980043153220]

Moist Heat or Steam Sterilization

[H980043153220]

Moist Heat or Steam Sterilization

[H980043153220]

Moist Heat or Steam Sterilization

[H980043153220]

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

Devices Manufactured by SYNTHES (U.S.A.) LP

• 10886982297280 - NA: 2024-09-11 SCHANZ PIN REMOVAL TOOL
• H9814871830 - Click'X: 2024-09-11 7.0MM TI CLICK'X® MONOAXIAL PEDICLE SCREW 90MM THRD LENGTH
• H9812982060 - NA: 2024-07-24 ANGLED LAMINA HOOK/ DUAL-OPENING SIDE
• H6792042280 - NA: 2024-07-24 3.5MM SHAFT SCREW 28MM
• H6792042320 - NA: 2024-07-24 3.5MM SHAFT SCREW 32MM
• H6792042340 - NA: 2024-07-24 3.5MM SHAFT SCREW 34MM
• H6792042360 - NA: 2024-07-24 3.5MM SHAFT SCREW 36MM
• H6792042380 - NA: 2024-07-24 3.5MM SHAFT SCREW 38MM