IQ SYSTEM SP-2695

GUDID 00841036145194

BIOMET MICROFIXATION, INC

Fluted surgical drill bit, reusable

• Primary Device ID: 00841036145194
• NIH Device Record Key: 75eb799c-3f81-4b3e-99ce-43f601952460
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IQ SYSTEM
• Version Model Number: SP-2695
• Catalog Number: SP-2695
• Company DUNS: 046189866
• Company Name: BIOMET MICROFIXATION, 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: 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(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841036145194 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062842

FDA Product Code

• HBE: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Sterilization

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

[00841036145194]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-22
• Device Publish Date: 2015-10-15

On-Brand Devices [IQ SYSTEM]

• 00841036145200: SP-2694
• 00841036145194: SP-2695
• 00841036140571: 72-1005
• 00841036140175: 72-1000
• 00841036138387: 72-1010
• 00841036284787: 72-1005
• 00841036284770: 72-1000