Comfortear™ 32-2004

GUDID 10810003223637

Comfortear™ Punctum Plugs economical bulk pack contain twenty (20) individually packaged non-sterile plugs per poly bag. Pedi, 0.5mm.

MICROSPECIALITIES, INC.

Lacrimal punctum plug

• Primary Device ID: 10810003223637
• NIH Device Record Key: 6474b57a-862f-4802-9175-c9d26567b723
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Comfortear™
• Version Model Number: 32-2004
• Catalog Number: 32-2004
• Company DUNS: 013469890
• Company Name: MICROSPECIALITIES, INC.
• Device Count: 20
• DM Exempt: false
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 203-874-1832
• Email: xx@xx.xx
• Phone: 203-874-1832
• Email: xx@xx.xx
• Phone: 203-874-1832
• Email: xx@xx.xx
• Phone: 203-874-1832
• Email: xx@xx.xx
• Phone: 203-874-1832
• Email: xx@xx.xx
• Phone: 203-874-1832
• Email: xx@xx.xx
• Phone: 203-874-1832
• Email: xx@xx.xx
• Phone: 203-874-1832
• Email: xx@xx.xx
• Phone: 203-874-1832
• Email: xx@xx.xx
• Phone: 203-874-1832
• Email: xx@xx.xx
• Phone: 203-874-1832
• Email: xx@xx.xx
• Phone: 203-874-1832
• Email: xx@xx.xx
• Phone: 203-874-1832
• Email: xx@xx.xx
• Phone: 203-874-1832
• Email: xx@xx.xx
• Phone: 203-874-1832
• Email: xx@xx.xx
• Phone: 203-874-1832
• Email: xx@xx.xx
• Phone: 203-874-1832
• Email: xx@xx.xx

Device Dimensions

• Outer Diameter: 0.5 Millimeter
• Outer Diameter: 0.5 Millimeter
• Outer Diameter: 0.5 Millimeter
• Outer Diameter: 0.5 Millimeter
• Outer Diameter: 0.5 Millimeter
• Outer Diameter: 0.5 Millimeter
• Outer Diameter: 0.5 Millimeter
• Outer Diameter: 0.5 Millimeter
• Outer Diameter: 0.5 Millimeter
• Outer Diameter: 0.5 Millimeter
• Outer Diameter: 0.5 Millimeter
• Outer Diameter: 0.5 Millimeter
• Outer Diameter: 0.5 Millimeter
• Outer Diameter: 0.5 Millimeter
• Outer Diameter: 0.5 Millimeter
• Outer Diameter: 0.5 Millimeter
• Outer Diameter: 0.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810003223630 [Unit of Use]
GS1	10810003223637 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050851

FDA Product Code

• LZU: Plug, Punctum

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-01-13
• Device Publish Date: 2019-01-03

On-Brand Devices [Comfortear™]

• 10810003223644: Comfortear™ Punctum Plug Inserter, 2 pkg
• 10810003223637: Comfortear™ Punctum Plugs economical bulk pack contain twenty (20) individually packaged non-s
• 10810003223620: Comfortear™ Punctum Plugs economical bulk pack contain twenty (20) individually packaged non-s
• 10810003223613: Comfortear™ Punctum Plugs economical bulk pack contain twenty (20) individually packaged non-s
• 10810003223606: Comfortear™ Punctum Plugs economical bulk pack contain twenty (20) individually packaged non-s
• 10810003223590: Comfortear™ Punctum Plugs economical bulk pack contain twenty (20) individually packaged non-s
• 30810003223587: Comfortear™ Punctum Plugs are packaged sterile and pre-loaded individually on the ergonomicall
• 30810003223570: Comfortear™ Punctum Plugs are packaged sterile and pre-loaded individually on the ergonomicall
• 30810003223563: Comfortear™ Punctum Plugs are packaged sterile and pre-loaded individually on the ergonomicall
• 30810003223556: Comfortear™ Punctum Plugs are packaged sterile and pre-loaded individually on the ergonomicall
• 30810003223549: Comfortear™ Punctum Plugs are packaged sterile and pre-loaded individually on the ergonomicall