Rigid Shield 4 cm F5350-4

GUDID 00858012005373

Rigid Shield 4 cm

Icad, Inc.

Radiation shielding apron

• Primary Device ID: 00858012005373
• NIH Device Record Key: 8fde7e1e-e0b6-4515-8739-7c24a19ec1ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rigid Shield 4 cm
• Version Model Number: 710707
• Catalog Number: F5350-4
• Company DUNS: 108870254
• Company Name: Icad, 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: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858012005373 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111299

FDA Product Code

• JAD: System, Therapeutic, X-Ray

Sterilization

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

[00858012005373]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-21
• Device Publish Date: 2016-09-20

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