SKEETER®

GUDID 00643169350670

FOOT CONTROL 3055607 SKEETER ROHS

MEDTRONIC XOMED, INC.

Foot-switch, electrical

• Primary Device ID: 00643169350670
• NIH Device Record Key: 5aadfbbe-4e4d-4d89-bde4-d6ea8431fae9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SKEETER®
• Version Model Number: 3055607
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169350670 [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: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-04-07

On-Brand Devices [SKEETER®]

• 00643169882676: DRILL 3055601 SKEETER OTO-TOOL ROHS
• 00643169789661: TRAY 3155615 OTO-TOOL STERILIZATION
• 00643169350670: FOOT CONTROL 3055607 SKEETER ROHS
• 00681490070348: TRAY 3155615 OTO-TOOL STERILIZATION
• 00681490066907: FOOT CONTROL 3055607 SKEETER
• 00681490066846: DRILL 3055601 SKEETER OTO-TOOL ROHS
• 00763000172145: TRAY 3155615 OTO-TOOL STERILIZATION