PowerForma®

GUDID 00681490073233

TUBING 3318501 POWERFORMA IRRIGATION

MEDTRONIC XOMED, INC.

Surgical irrigation tubing set, single-use Surgical irrigation tubing set, single-use

• Primary Device ID: 00681490073233
• NIH Device Record Key: baed3ddb-92d9-4343-927e-15f4440d2806
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PowerForma®
• Version Model Number: 3318501
• 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: 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)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	00681490073233 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K791407

FDA Product Code

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

Sterilization

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

[00681490073233]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00681490073233]

Ethylene Oxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-04-23
• Device Publish Date: 2016-04-23

On-Brand Devices [PowerForma®]

• 00681490073233: TUBING 3318501 POWERFORMA IRRIGATION
• 00681490051569: ADAPTER 1994025 POWERFORMA HANDPIECE
• 20681490049133: TUBING 1895520 5PK PWRFORMA TO XPS IRRIG