Shield, Eye, Radiological

Device Code: 5296

Product Code(s): IWS

Device Classification Information

• Device Type ID: 5296
• Device Name: Shield, Eye, Radiological
• Regulation Description: Personnel Protective Shield.
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 892.6500 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: IWS
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 12-282 ISO 12609-1 First Edition 2013-07-15
  Eyewear For Protection Against Intense Light Sources Used On Humans And Animals For Cosmetic And Medical Applications -- Part 1: Specification For Products
• 12-283 ISO 12609-2 First Edition 2013-07-15
  Eyewear For Protection Against Intense Light Sources Used On Humans And Animals For Cosmetic And Medical Applications -- Part 2: Guidance For Use

Total Product Life Cycle

• Device Type ID: 5296
• Device: Shield, Eye, Radiological
• Product Code: IWS
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Personnel Protective Shield.
• CFR Regulation Number: 892.6500 [🔎]

TPLC Last Update: 2019-04-02 21:03:51