Comfortear™ 24-2007

GUDID 30810003223556

Comfortear™ Punctum Plugs are packaged sterile and pre-loaded individually on the ergonomically designed Comfortear™ Insertion Tool in an impact-minimizing tray. Packaged two (2) individual sterile trays per box, the Comfortear™ individual sterile trays reduce the potential for unnecessary waste when only a single occulder is required. Medium, 0.8mm.

MICROSPECIALITIES, INC.

Lacrimal punctum plug

• Primary Device ID: 30810003223556
• NIH Device Record Key: dff70444-5704-4617-ac19-40af66ada8d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Comfortear™
• Version Model Number: 24-2007
• Catalog Number: 24-2007
• Company DUNS: 013469890
• Company Name: MICROSPECIALITIES, INC.
• Device Count: 1
• 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: 0.8 Millimeter
• Outer Diameter: 0.8 Millimeter
• Outer Diameter: 0.8 Millimeter
• Outer Diameter: 0.8 Millimeter
• Outer Diameter: 0.8 Millimeter
• Outer Diameter: 0.8 Millimeter
• Outer Diameter: 0.8 Millimeter
• Outer Diameter: 0.8 Millimeter
• Outer Diameter: 0.8 Millimeter
• Outer Diameter: 0.8 Millimeter
• Outer Diameter: 0.8 Millimeter
• Outer Diameter: 0.8 Millimeter
• Outer Diameter: 0.8 Millimeter
• Outer Diameter: 0.8 Millimeter
• Outer Diameter: 0.8 Millimeter
• Outer Diameter: 0.8 Millimeter
• Outer Diameter: 0.8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10810003223552 [Primary]
GS1	30810003223556 [Package]; Contains: 10810003223552; Package: Box [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050851

FDA Product Code

• LZU: Plug, Punctum

Sterilization

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

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