Light Shield™

GUDID 20809160022051

MEDICAL ACTION INDUSTRIES INC.

Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile

• Primary Device ID: 20809160022051
• NIH Device Record Key: 68df160e-418a-42ad-93eb-39704fefd55c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Light Shield™
• Version Model Number: NB8000
• Company DUNS: 092364462
• Company Name: MEDICAL ACTION INDUSTRIES INC.
• Device Count: 250
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10809160022054 [Unit of Use]
GS1	20809160022051 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020304

FDA Product Code

• FTA: Light, surgical, accessories

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[20809160022051]

Radiation Sterilization

[20809160022051]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-22
• Device Publish Date: 2016-08-20

On-Brand Devices [Light Shield™]

• 20809160022174: Light Shield: Rigid Handle NS 2400/Cs