E5425 Band Bag with Elastic 81x46cm E5425

GUDID 00816953022422

EXACT MEDICAL MANUFACTURING, INC.

Instrument/equipment drape, single-use, sterile

• Primary Device ID: 00816953022422
• NIH Device Record Key: 2e8a19ea-5aed-4473-829d-492b90521bd8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: E5425 Band Bag with Elastic 81x46cm
• Version Model Number: E5425
• Catalog Number: E5425
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816953022415 [Primary]
GS1	00816953022422 [Package]; Contains: 00816953022415; Package: Inner Case [50 Units]; In Commercial Distribution
GS1	00816953022439 [Package]; Contains: 00816953022415; Package: Case [100 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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-17

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