LB56

GUDID 00724995153182

The STERIS Harmony rSheild is a radiation proton device with 23.6-inch tube mounts to the STERIS Lighting Visualization Systems.

STERIS CORPORATION

Radiation shielding panel, fixed Radiation shielding panel, fixed Radiation shielding panel, fixed Radiation shielding panel, fixed Radiation shielding panel, fixed Radiation shielding panel, fixed Radiation shielding panel, fixed Radiation shielding panel, fixed Radiation shielding panel, fixed Radiation shielding panel, fixed Radiation shielding panel, fixed Radiation shielding panel, fixed Radiation shielding panel, fixed Radiation shielding panel, fixed Radiation shielding panel, fixed Radiation shielding panel, fixed

• Primary Device ID: 00724995153182
• NIH Device Record Key: 59283234-d052-4a7b-a1fa-7a5b3e91ae68
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: rShield
• Catalog Number: LB56
• Company DUNS: 036985604
• Company Name: STERIS CORPORATION
• 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: true
• 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: true

Customer Support Contacts

• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00724995153182 [Primary]

FDA Product Code

• KPY: Shield, protective, personnel

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: 2021-04-08
• Device Publish Date: 2021-03-31

Devices Manufactured by STERIS CORPORATION

• 00724995152970 - NA: 2021-04-12 The Plastic LightHandle non-sterile is for receiving disposable light handle cover and used with HarmonyAIR and Harmony Surgical
• 00724995152987 - NA: 2021-04-12 The Aluminum Sterilizable Handle is a reusable surgical light handle without sterile surgeon control.
• 00724995152994 - NA: 2021-04-12 The Surgeon Control Sterilizable Handle provides sterile surgeon control of surgical light intensity, pattern, power and positio
• 00724995153007 - NA: 2021-04-12 The Silicone Ring is used with the Sterilizable Aluminum Light Handle.
• 00724995156428 - NA: 2021-04-12 The 2-inch TLT Pad - Head Section is used with surgical tables.
• 00724995156435 - NA: 2021-04-12 The 2-inch TLT Pad for Back Section is used with surgical tables.
• 00724995156442 - NA: 2021-04-12 The 2-inch TLT Table Pads Complete Set is used with the STERIS Cmax, 4085 and 5085 General Surgical Table.
• 00724995156459 - NA: 2021-04-12 The 5085 Harmony Standard Headrest with 2-inch PRS Pads is used with the 5085 Harmony Surgical Table.