Icon Surgical MDIC5454150

GUDID 16975424194561

Microscope drape

EXACT MEDICAL MANUFACTURING, INC.

Medical equipment drape, single-use

• Primary Device ID: 16975424194561
• NIH Device Record Key: 0a069228-3a62-480a-889a-8a8411ac02fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Icon Surgical
• Version Model Number: MDIC5454150
• Catalog Number: MDIC5454150
• Company DUNS: 014464314
• Company Name: EXACT MEDICAL MANUFACTURING, 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: 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	06975424194564 [Primary]
GS1	16975424194561 [Package]; Contains: 06975424194564; Package: Inner Case [10 Units]; In Commercial Distribution
GS1	26975424194568 [Package]; Package: Case [1 Units]; In Commercial Distribution

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: 2023-11-08
• Device Publish Date: 2023-10-31

On-Brand Devices [Icon Surgical]

• 00850003355573: Microscope drape
• 16975424194561: Microscope drape