SuperFlex 3178J

GUDID 00841668115077

SuperFlex Punctum Plug 0.8mm D x 1.5mm L - Twin Pack

KATENA PRODUCTS, INC.

Lacrimal punctum plug

• Primary Device ID: 00841668115077
• NIH Device Record Key: 34899336-eb1b-478a-bc50-5ee8ce453dcc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SuperFlex
• Version Model Number: 3178J
• Catalog Number: 3178J
• Company DUNS: 085668598
• Company Name: KATENA PRODUCTS, INC.
• Device Count: 1
• 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: 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: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841668115077 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991130

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-03-31

On-Brand Devices [SuperFlex]

• 00841668115091: SuperFlex Punctum Plug 1.3mm D x 2.0mm L - Twin Pack
• 00841668115084: SuperFlex Punctum Plug 0.9mm D x 1.7mm L - Twin Pack
• 00841668115077: SuperFlex Punctum Plug 0.8mm D x 1.5mm L - Twin Pack
• 00841668115060: SuperFlex Punctum Plug 0.7mm D x 1.4mm L - Twin Pack
• 00841668115053: SuperFlex Punctum Plug 0.6mm D x 1.3mm L - Twin Pack
• 00841668115046: SuperFlex Punctum Plug 0.5mm D x 1.2mm L - Twin Pack
• 00841668115039: SuperFlex Punctum Plug 0.4mm D x 1.1mm L - Twin Pack
• 00841668115022: SuperFlex Punctum Plug 0.3mm D x 1.1mm L - Twin Pack
• 00841668115015: SuperFlex Punctum Plug 1.2mm D x 2.0mm L - Twin Pack
• 00841668115008: SuperFlex Punctum Plug 1.1mm D x 2.0mm L - Twin Pack
• 00841668114995: SuperFlex Punctum Plug 1.0mm D x 1.8mm - Twin Pack
• 00841668114537: SuperFlex Punctum Plug 1.3mm D x 2.0mm L - 2 per box
• 00841668114520: SuperFlex Punctum Plug 0.9mm D x 1.7mm L - 2 per box
• 00841668114513: SuperFlex Punctum Plug 0.8mm D x 1.5mm L - 2 per box
• 00841668114506: SuperFlex Punctum Plug 0.7mm D x 1.4mm L - 2 per box
• 00841668114490: SuperFlex Punctum Plug 0.6mm D x 1.3mm L - 2 per box
• 00841668114483: SuperFlex Punctum Plug 0.5mm D x 1.2mm L - 2 per box
• 00841668114476: SuperFlex Punctum Plug 0.4mm D x 1.1mm L - 2 per box
• 00841668114469: SuperFlex Punctum Plug 0.3mm D x 1.1mm L - 2 per box
• 00841668114452: SuperFlex Punctum Plug 1.2mm D x 2.0mm L - 2 per box
• 00841668114445: SuperFlex Punctum Plug 1.1mm D x 2.0mm L - 2 per box
• 00841668114438: SuperFlex Punctum Plug 1.0mm D x 1.8mm - 2 per box