03305500

GUDID H980033055000

MANDIBLE EXTERNAL FIXATOR 500MM ROD KIT

SYNTHES (U.S.A.) LP

External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable

• Primary Device ID: H980033055000
• NIH Device Record Key: ccfcc744-df1e-4566-885a-53e5f2f0db6f
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 03.305.500
• Catalog Number: 03305500
• 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: true
• 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	10887587010052 [Primary]
HIBCC	H980033055000 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050378

FDA Product Code

• MQN: EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR

Sterilization

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

[H980033055000]

Moist Heat or Steam Sterilization

[H980033055000]

Moist Heat or Steam Sterilization

[H980033055000]

Moist Heat or Steam Sterilization

[H980033055000]

Moist Heat or Steam Sterilization

[H980033055000]

Moist Heat or Steam Sterilization

[H980033055000]

Moist Heat or Steam Sterilization

[H980033055000]

Moist Heat or Steam Sterilization

[H980033055000]

Moist Heat or Steam Sterilization

[H980033055000]

Moist Heat or Steam Sterilization

[H980033055000]

Moist Heat or Steam Sterilization

[H980033055000]

Moist Heat or Steam Sterilization

[H980033055000]

Moist Heat or Steam Sterilization

[H980033055000]

Moist Heat or Steam Sterilization

[H980033055000]

Moist Heat or Steam Sterilization

[H980033055000]

Moist Heat or Steam Sterilization

[H980033055000]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-14

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

• H679022101060 - NA: 2024-02-27 2.4MM VA LOCKING SCREW STARDRIVE 6MM
• H679022221140 - NA: 2024-02-27 5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/14MM
• H679022221160 - NA: 2024-02-27 5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/16MM
• 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