SecureShield© EP 12" x 17" Scatter Reducing Drape

GUDID 10860004894657

Excellent protection for device implant procedures such as Bi-V pacing, etc. Specially designed scoop fenestration allows easy access to site and maximum radiation protection. Specifically designed to protect the physician’s hand, body and head. The unique half-moon fenestration is large enough to allow easy access at the entry point, but small enough to block dangerous scatter radiation.

Barrier Technologies, LLC

Patient radiation shielding pad/drape, single-use

• Primary Device ID: 10860004894657
• NIH Device Record Key: 16480248-d2b9-449d-89a4-449a43a094ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SecureShield© EP 12" x 17" Scatter Reducing Drape
• Version Model Number: SS-5400
• Company DUNS: 621134084
• Company Name: Barrier Technologies, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10860004894657 [Primary]

FDA Product Code

• KPY: Shield, Protective, Personnel

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: 2022-09-06
• Device Publish Date: 2022-08-29

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