CCORE 19297

GUDID 00817602022664

Drape, Ortho, Beach Chair

C-CORE MEDICAL, INC.

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• Primary Device ID: 00817602022664
• NIH Device Record Key: 401c10ea-f2e8-4a32-bf93-d13f7401f41c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CCORE
• Version Model Number: 19297
• Catalog Number: 19297
• Company DUNS: 096989103
• Company Name: C-CORE MEDICAL, 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	00817602022657 [Primary]
GS1	00817602022664 [Package]; Contains: 00817602022657; Package: Case [12 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-05
• Device Publish Date: 2020-09-25

On-Brand Devices [CCORE]

• 00817602022664: Drape, Ortho, Beach Chair
• 00817602022640: Cover, Table Drape