SKEETER

GUDID 00763000378004

DRILL 3055601 SKEETER OTO-TOOL ROHS

MEDTRONIC XOMED, INC.

Bone/joint surgical power tool motor, electric Bone/joint surgical power tool motor, electric Bone/joint surgical power tool motor, electric Bone/joint surgical power tool motor, electric Bone/joint surgical power tool motor, electric Bone/joint surgical power tool motor, electric Bone/joint surgical power tool motor, electric Bone/joint surgical power tool motor, electric Bone/joint surgical power tool motor, electric Bone/joint surgical power tool motor, electric

• Primary Device ID: 00763000378004
• NIH Device Record Key: c44a70dc-f5b5-442f-9731-243f1889a5f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SKEETER
• Version Model Number: 3055601
• Company DUNS: 835465063
• Company Name: MEDTRONIC XOMED, 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: false
• Lot Batch: false
• Serial Number: true
• 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)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000378004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K833874

FDA Product Code

• ERL: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Sterilization

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

[00763000378004]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00763000378004]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00763000378004]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00763000378004]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00763000378004]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00763000378004]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00763000378004]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00763000378004]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00763000378004]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00763000378004]

Moist Heat or Steam Sterilization;Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-14
• Device Publish Date: 2022-11-05

On-Brand Devices [SKEETER]

• 00763000299293: TRAY 3155615 OTO-TOOL STERILIZATION
• 00763000378004: DRILL 3055601 SKEETER OTO-TOOL ROHS