MULTILOC 03019001

GUDID H679030190010

RADIOGRAPHIC RULER FOR MULTILOC HUMERAL NAIL

SYNTHES (U.S.A.) LP

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• Primary Device ID: H679030190010
• NIH Device Record Key: b5e8a139-5ec6-4e12-891a-151571341cc8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MULTILOC
• Version Model Number: 03.019.001
• Catalog Number: 03019001
• 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: false
• 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	07611819425514 [Direct Marking]
GS1	10886982069368 [Primary]
HIBCC	H679030190010 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120807

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

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

[H679030190010]

Moist Heat or Steam Sterilization

[H679030190010]

Moist Heat or Steam Sterilization

[H679030190010]

Moist Heat or Steam Sterilization

[H679030190010]

Moist Heat or Steam Sterilization

[H679030190010]

Moist Heat or Steam Sterilization

[H679030190010]

Moist Heat or Steam Sterilization

[H679030190010]

Moist Heat or Steam Sterilization

[H679030190010]

Moist Heat or Steam Sterilization

[H679030190010]

Moist Heat or Steam Sterilization

[H679030190010]

Moist Heat or Steam Sterilization

[H679030190010]

Moist Heat or Steam Sterilization

[H679030190010]

Moist Heat or Steam Sterilization

[H679030190010]

Moist Heat or Steam Sterilization

[H679030190010]

Moist Heat or Steam Sterilization

[H679030190010]

Moist Heat or Steam Sterilization

[H679030190010]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-05-07
• Device Publish Date: 2015-09-14

On-Brand Devices [MULTILOC]

• H679SD030190060: PERCUTANEOUS INSERTION HANDLE MULTILOC PROXIMAL HUMERUS NAIL
• 07611819427235: END CAP RULER F/MULTILOC HUMERAL NAILING SYSTEM
• H679030190010: RADIOGRAPHIC RULER FOR MULTILOC HUMERAL NAIL
• H67904019015S0: TI MULTILOC END CAP F/MULTILOC NAIL/15MM EXTENSION-STERILE
• H67904019010S0: TI MULTILOC END CAP F/MULTILOC NAIL/10MM EXTENSION-STERILE
• H67904019005S0: TI MULTILOC END CAP F/MULTILOC NAIL/5MM EXTENSION-STERILE
• H67904019002S0: TI MULTILOC END CAP F/MULTILOC NAIL/2MM EXTENSION-STERILE
• H67904019000S0: TI MULTILOC END CAP F/MULTILOC NAIL/0MM EXTENSION-STERILE