SPONGE 400750 ELVIS 10PK ANTI-FOG

SPONGE 400750 ELVIS 10PK ANTI
Merocel® ELVIS® - 400750

Device Description

A liquid substance intended to be used to prevent the occurrence of condensed vapour (fog) on the lens of an endoscopic instrument during treatment. It will typically be used on the lens of an endoscopic camera where the warmth from an enclosed body cavity creates the conditions to produce fog on the lens. This device will typically be contained in a spray can, bottle, or squeeze bottle. After application, this device cannot be reused.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: OCT

Device Name: Anti Fog Solution And Accessories, Endoscopy

Device Class: 2

Physical State: anti fog solution; applicator- typically a foam pad or sponge, spray can, bottle, or cloth; container to hold solution

Definition: To prevent, reduce or eliminate condensation (fog) on endoscopic lens.

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Apply solution to lens, typically by spraying or wiping.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: endoscopic lens

Regulation Number: 876.1500

Third Party Flag: Y

Medical Specialty: GU

Code: EFQ

Device Name: Gauze/Sponge, Internal

Device Class: U

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: SU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: 1

Implant Flag: N

Target Area: N/A

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Identifiers

Device Id: 20681490105679

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