- Physicians Office Resource

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

Storage Environment Humidity - Percent (%) Relative Humidity

75.00
10.00

Storage Environment Temperature - Degrees Celsius

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 Identifiers

Device 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

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