OsteoMed™ Power Driver 68-OM-SD

GUDID 00873263003657

OsteoMed Singe use Sterile Power Driver, 1x, for use with WayPoint Combo Driver bit

FHC, INC.

Neurological stereotactic surgery system

• Primary Device ID: 00873263003657
• NIH Device Record Key: bce5d340-aac7-47b7-b00f-8867c2ccbf8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OsteoMed™ Power Driver
• Version Model Number: 68-OM-SD-00365
• Catalog Number: 68-OM-SD
• Company DUNS: 108179458
• Company Name: FHC, INC.
• 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: true
• 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)326-2905
• Email: fhcinc@fh-co.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263003657 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092192

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

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

[00873263003657]

Radiation 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: 2016-09-17

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