Ova Shield - no closure

GUDID G031807SRL0

Ova Shield-Plain-Small - 0.5mm Regular Lead (RL)

Shielding International Inc.

Gonad radiation shield

• Primary Device ID: G031807SRL0
• NIH Device Record Key: 4b048db3-c094-40e3-a664-49ac18f9abc2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ova Shield - no closure
• Version Model Number: 807SRL
• Company DUNS: 009647322
• Company Name: Shielding International 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: true
• 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
HIBCC	G031807SRL0 [Primary]

FDA Product Code

• IWT: Shield, Gonadal

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: 2023-10-20
• Device Publish Date: 2023-10-12

Devices Manufactured by Shielding International Inc.

• G031WABRX2XFLF0 - Wrap Around Back Relief Apron - BRX Belt: 2023-10-25 Wrap Around Back Relief Apron - BRX Belt XX-Large Female-Lead Free: 0.5mm Front / 1.0mm @ overlap / 0.25mm Back (LF)
• G031WABRX2XFLFL0 - Wrap Around Back Relief Apron - BRX Belt: 2023-10-25 Wrap Around Back Relief Apron - BRX Belt XX-Large Female- Lead Free: 0.35mm- Front / 0.7mm @ overlap / 0.25mm Back (LFL)
• G031WABRX2XFNL0 - Wrap Around Back Relief Apron - BRX Belt: 2023-10-25 Wrap Around Back Relief Apron - BRX Belt XX-Large Female-Non Lead: 0.5mm Front / 1.0mm @ overlap / 0.25mm Back (NL)
• G031WABRX2XFNLL0 - Wrap Around Back Relief Apron - BRX Belt: 2023-10-25 Wrap Around Back Relief Apron - BRX Belt XX-Large Female- Non Lead: 0.35mm Front / 0.7mm @ overlap / 0.25mm Back (NLL)
• G031WABRX2XFRL0 - Wrap Around Back Relief Apron - BRX Belt: 2023-10-25 Wrap Around Back Relief Apron - BRX Belt XX-Large Female- Regular Lead: 0.5mm Front / 1.0mm Overlap / 0.3mm Back (RL)
• G031WABRX2XFRLL0 - Wrap Around Back Relief Apron - BRX Belt: 2023-10-25 Wrap Around Back Relief Apron - BRX Belt XX-Large Female- Regular Lead: 0.35mm Front / 0.7mm @ Overlap / 0.25mm Back (RLL)
• G031WABRX2XFTL0 - Wrap Around Back Relief Apron - BRX Belt: 2023-10-25 Wrap Around Back Relief Apron - BRX Belt XX-Large Female-TL Lite Ply: 0.5mm Front / 1.0mm @ overlap / 0.25mm Back (TL)
• G031WABRX2XFTLL0 - Wrap Around Back Relief Apron - BRX Belt: 2023-10-25 Wrap Around Back Relief Apron - BRX Belt XX-Large Female-TL Lite Ply: 0.35mm Front / 0.7mm @ overlap / 0.25mm Back (TLL)