C-Core 90121

GUDID 00817602022602

Gown, Surgical, Std, Lg, set in, 40gsm SMS ASAR

EXACT MEDICAL MANUFACTURING, INC.

Surgical gown, single-use

• Primary Device ID: 00817602022602
• NIH Device Record Key: 05918723-c8b4-4d73-b0aa-721fc6e41bb1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C-Core
• Version Model Number: 90121
• Catalog Number: 90121
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817602022596 [Primary]
GS1	00817602022602 [Package]; Contains: 00817602022596; Package: Case [44 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: 2020-03-16
• Device Publish Date: 2020-03-06

On-Brand Devices [C-Core]

• 00817602022626: Gown, Surgical, Std, XLg, set in, 40gsm SMS ASAR
• 00817602022602: Gown, Surgical, Std, Lg, set in, 40gsm SMS ASAR