Medtronic 31304

GUDID 06975085708391

Targeting Unit Cover, PE, adapters, 50x100cm

EXACT MEDICAL MANUFACTURING, INC.

Medical equipment drape, single-use

• Primary Device ID: 06975085708391
• NIH Device Record Key: 5b8a8c79-a270-483f-8aee-caed6c73cde0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medtronic
• Version Model Number: 31304
• Catalog Number: 31304
• Company DUNS: 014464314
• Company Name: EXACT MEDICAL MANUFACTURING, INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06975085708391 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101689

FDA Product Code

• KKX: Drape, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-11
• Device Publish Date: 2023-04-03

On-Brand Devices [Medtronic]

• 06975085708407: Control Unit Drape,PE w/Elastic Bands 25x100cm
• 06975085708391: Targeting Unit Cover, PE, adapters, 50x100cm