EYE BUBBLE
BOVIE - 0002
Device Description
A mechanical shield intended to be fitted over the eyes to prevent the intrusion of light, typically to facilitate rest or sleep in illuminated environments and/or at home. It typically consists of an external covering made of an opaque plastic, or other appropriate material, that does not allow the passage of light and that is lined with a padded inner liner (e.g., foam, gauze); it is held in place with a strap(s). It is intended for single-patient use.
Environmental Conditions
- 75.00
- 10.00
- 30.00
- 10.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: HOY
Device Name: Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: OP
Review Code: N/A
Technical Method: Y
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 886.4750
Third Party Flag: N
Medical Specialty: OP
Device IdentifiersDevice Id: 10607151000025
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00607151000028
Package Quantity: 10
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: BOX
Device Id: 00607151000028
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A