C-Core Drape, Sheet, SMS 40"x63" E201301

GUDID 10852205007707

Drape, Sheet, 2Ply, 40"x63"

EXACT MEDICAL MANUFACTURING, INC.

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• Primary Device ID: 10852205007707
• NIH Device Record Key: 1c9c3ea2-74d0-44c1-9c2c-642d3a1cd85f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C-Core Drape, Sheet, SMS 40"x63"
• Version Model Number: E201301
• Catalog Number: E201301
• 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	00852205007700 [Primary]
GS1	10852205007707 [Package]; Contains: 00852205007700; Package: case [60 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101598

FDA Product Code

• KKX: Drape, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-08
• Device Publish Date: 2016-09-15

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