EndoArmor™ Plus SGE-499-10

GUDID 00191506004026

EndoArmor Gown, Plus

BOSTON SCIENTIFIC CORPORATION

Isolation gown, single-use

• Primary Device ID: 00191506004026
• NIH Device Record Key: 14f48f23-75eb-4025-812e-b3ae0ae6cd6a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EndoArmor™ Plus
• Version Model Number: SGE-499-10
• Catalog Number: SGE-499-10
• Company DUNS: 021717889
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Device Count: 10
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00191506004019 [Primary]
GS1	00191506004026 [Package]; Contains: 00191506004019; Package: [10 Units]; In Commercial Distribution
GS1	08714729989608 [Unit of Use]

FDA Product Code

• OEA: Non-surgical isolation gown

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-20
• Device Publish Date: 2020-04-10

On-Brand Devices [EndoArmor™ Plus]

• 00191506004026: EndoArmor Gown, Plus
• 00816849016481: EndoArmor Gown, Plus