TOMOFIX 324168

GUDID 07611819254701

2.0MM TOMOFIX(TM) GUIDE SLEEVE

SYNTHES (U.S.A.) LP

Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable

• Primary Device ID: 07611819254701
• NIH Device Record Key: e0c8fcd0-3c77-4927-a961-ab06a495c7e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TOMOFIX
• Version Model Number: 324.168
• Catalog Number: 324168
• Company DUNS: 832637081
• Company Name: SYNTHES (U.S.A.) LP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	07611819254701 [Direct Marking]
GS1	10886982191120 [Primary]
HIBCC	H6793241680 [Secondary]

FDA Product Code

• FZX: Guide, surgical, instrument

Sterilization

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

[07611819254701]

Moist Heat or Steam Sterilization

[07611819254701]

Moist Heat or Steam Sterilization

[07611819254701]

Moist Heat or Steam Sterilization

[07611819254701]

Moist Heat or Steam Sterilization

[07611819254701]

Moist Heat or Steam Sterilization

[07611819254701]

Moist Heat or Steam Sterilization

[07611819254701]

Moist Heat or Steam Sterilization

[07611819254701]

Moist Heat or Steam Sterilization

[07611819254701]

Moist Heat or Steam Sterilization

[07611819254701]

Moist Heat or Steam Sterilization

[07611819254701]

Moist Heat or Steam Sterilization

[07611819254701]

Moist Heat or Steam Sterilization

[07611819254701]

Moist Heat or Steam Sterilization

[07611819254701]

Moist Heat or Steam Sterilization

[07611819254701]

Moist Heat or Steam Sterilization

[07611819254701]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-04-06
• Device Publish Date: 2016-12-31

On-Brand Devices [TOMOFIX]

• 07611819254701: 2.0MM TOMOFIX(TM) GUIDE SLEEVE
• H679440895S0: TI TOMOFIX MEDIAL DISTAL FEMUR PL-4 HOLES/LT-STERILE
• H6794408950: TI TOMOFIX MEDIAL DISTAL FEMUR PLATE-4 HOLES/LEFT
• H679440885S0: TI TOMOFIX MEDIAL DISTAL FEMUR PL-4 HOLES/RT-STERILE
• H6794408850: TI TOMOFIX MEDIAL DISTAL FEMUR PLATE-4 HOLES/RIGHT