INTEGO 001-708

GUDID 00718175001714

Shield, Vial, Tungsten for 30 ml for Hospira vials. Includes lifting handle

BIODEX MEDICAL SYSTEMS, INC.

Vial radiation shield

• Primary Device ID: 00718175001714
• NIH Device Record Key: 1fa83ff5-fc10-448a-b3a6-b95bc1e6084a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTEGO
• Version Model Number: 001-708
• Catalog Number: 001-708
• Company DUNS: 043833813
• Company Name: BIODEX MEDICAL SYSTEMS, INC.
• 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: false
• 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	00718175001714 [Primary]

FDA Product Code

• IWW: Shield, Vial

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: 2019-01-15
• Device Publish Date: 2018-12-15

On-Brand Devices [INTEGO]

• 00718175001721: Shipping Container, Intego
• 00718175001714: Shield, Vial, Tungsten for 30 ml for Hospira vials. Includes lifting handle