Halyard Scatter Radiation Shields

GUDID 10816611026127

ANGIOSYSTEMS, INCORPORATED

Patient radiation shielding pad/drape, single-use

• Primary Device ID: 10816611026127
• NIH Device Record Key: 382b7408-75cf-4a54-b07e-25a624a27e9a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Halyard Scatter Radiation Shields
• Version Model Number: 49039 Multi-Purpose Shield Drape W/ FEN L2
• Company DUNS: 144884467
• Company Name: ANGIOSYSTEMS, INCORPORATED
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00816611026120 [Primary]
GS1	10816611026127 [Package]; Contains: 00816611026120; Package: CASE [45 Units]; In Commercial Distribution

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: 2025-02-07
• Device Publish Date: 2025-01-30

On-Brand Devices [Halyard Scatter Radiation Shields]

• 10816611026356: 49079 Peripheral Shield Drape L2 NS
• 10816611026349: 49077 Biliary Shield Drape L2 NS
• 10816611026332: 49075 Jugular Shield Drape L2 NS
• 10816611026325: 49073 Subclavian Shield Drape L2 NS
• 10816611026318: 49071 Angiography Shield Drape L2 NS
• 10816611026301: 49069 Biopsy Shield Drape L2 NS
• 10816611026295: 49038 Multi-Purpose Shield Drape W/ FEN L2 NS
• 10816611026288: 49036 Multi-Purpose Shield Drape L2 NS
• 10816611026271: 49021 Peripheral Shield Drape L1 NS
• 10816611026264: 49017 Biliary Shield Drape L1 NS
• 10816611026257: 49000 Jugular Shield Drape L1 NS
• 10816611026240: 48989 Subclavian Shield Drape L1 NS
• 10816611026233: 48987 Angiography Shield Drape L1 NS
• 10816611026226: 48959 Multi-Purpose Shield W/ FEN L1 NS
• 10816611026219: 48957 Multi Purpose Shield L1 NS
• 10816611026189: 49080 Peripheral Shield Drape L2
• 10816611026172: 49078 Biliary Shield Drape L2
• 10816611026165: 49076 Jugular Shield Drape L2
• 10816611026158: 49074 Subclavian Shield Drape L2
• 10816611026141: 49072 Angiography Shield Drape L2
• 10816611026134: 49070 Biopsy Shield Drape L2
• 10816611026127: 49039 Multi-Purpose Shield Drape W/ FEN L2
• 10816611026110: 49037 Multi-Purpose Shield Drape L2
• 10816611026103: 49035 Peripheral Shield Drape L1
• 00816611026090: 49020 Biliary Shield Drape L1
• 10816611026080: 49016 Jugular Shield Drape L1
• 10816611026073: 48990 Subclavian Shield Drape L1
• 10816611026066: 48988 Angiography Shield Drape L1
• 10816611026059: 48986 Multi-Purpose Shield W/ FEN L1
• 00816611026045: 48958 Multi Purpose Shield L1