C-Core Drape, Sheet, SMS 63"x77" E201501

GUDID 00852205007717

Drape, Sheet, 2Ply, 63"x77"

EXACT MEDICAL MANUFACTURING, INC.

Patient surgical drape, single-use, sterile

• Primary Device ID: 00852205007717
• NIH Device Record Key: e3221297-5af6-407c-96d9-516f68f1dd4a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C-Core Drape, Sheet, SMS 63"x77"
• Version Model Number: E201501
• Catalog Number: E201501
• 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	00852205007717 [Primary]

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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