Alcon Eye-Pak

GUDID 10380651020204

Eye Pak* 1020 Plastic Ophthalmic Drape INCISE

Alcon Laboratories, Inc.

Patient surgical drape, single-use, sterile

• Primary Device ID: 10380651020204
• NIH Device Record Key: 4a519dcc-9df3-4589-82f9-ffb1ef018010
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alcon Eye-Pak
• Version Model Number: 8065102020
• Company DUNS: 008018525
• Company Name: Alcon Laboratories, 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: 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: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380651020207 [Primary]
GS1	10380651020204 [Package]; Contains: 00380651020207; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K830822

FDA Product Code

• HMT: Drape, patient, ophthalmic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-08
• Device Publish Date: 2016-09-24

On-Brand Devices [Alcon Eye-Pak]

• 10380657407450: Eye Pak* 7407 Tray Support Cover
• 10380651173207: Eye Pak* 1173 Plastic/Non-woven Ophthalmic Drape APERTURE POUCH
• 10380651172200: Eye Pak* 1172 Plastic/Non-woven Ophthalmic Drape INCISE POUCH
• 10380651171203: Eye Pak* 1171 Plastic/Non-woven Ophthalmic Drape APERTURE POUCH
• 10380651170206: Eye Pak* 1170 Plastic/Non-woven Ophthalmic Drape INCISE POUCH
• 10380651130200: Eye Pak* 1130 Non-woven Ophthalmic Drape INCISE POUCHES FAN FOLD
• 10380651129204: Eye Pak* 1129 Plastic Ophthalmic Drape APERTURE POUCH
• 10380651126203: Eye Pak* 1126 Plastic Ophthalmic Drape INCISE
• 10380651120201: Eye Pak* 1120 Plastic Ophthalmic Drape INCISE
• 10380651063201: Eye Pak* 1063 Non-woven Ophthalmic Drape APERTURE
• 10380651062204: Eye Pak* 1062 Non-woven Ophthalmic Drape INCISE
• 10380651056203: Eye Pak* 1056 Plastic Lash Drape
• 10380651055206: Eye Pak* 1055 Plastic Lash Drape
• 10380651050201: Eye Pak* 1050 Non-woven Ophthalmic Drape INCISE POUCHES
• 10380651045207: Eye Pak* 1045 Plastic Ophthalmic Drape INCISE POUCH
• 10380651044200: Eye Pak* 1044 Non-woven Ophthalmic Drape INCISE POUCH
• 10380651043203: Eye Pak* 1043 Non-woven Ophthalmic Drape APERTURE POUCH
• 10380651042206: Eye Pak* 1042 Non-woven Ophthalmic Drape INCISE POUCH
• 10380651041209: Eye Pak* 1041 Plastic Ophthalmic Drape APERTURE POUCH
• 10380651040202: Eye Pak* 1040 Plastic Ophthalmic Drape INCISE POUCH
• 10380651038209: Eye Pak* 1034 Instrument Panel/Utility Drape
• 10380651034010: Eye Pak* 1034 Table Cover
• 10380651033204: Eye Pak* 1033 Non-woven Ophthalmic Drape APERTURE POUCHES
• 10380651032207: Eye Pak* 1032 Non Woven Opthalmic Drape INCISE POUCHES
• 10380651031200: Eye Pak* 1031 Non-woven Ophthalmic Drape APERTURE POUCHES
• 10380651030203: Eye Pak* 1030 Non-woven Ophthalmic Drape INCISE POUCHES
• 10380651029207: Eye Pak* 1029 Plastic Ophthalmic Drape INCISE POUCH
• 10380651028200: Eye Pak* 1028 Plastic Ophthalmic Drape-Strabismus APERTURE
• 10380651027203: Eye Pak* 1027 Fluid Catch Bag For Ophthalmic Drape
• 10380651026206: Eye Pak* 1026 Plastic Ophthalmic Drape APERTURE
• 10380651023205: Eye Pak* 1023 Non-woven Ophthalmic Drape APERTURE
• 10380651022208: Eye Pak* 1022 Non-woven Ophthalmic Drape INCISE
• 10380651021201: Eye Pak* 1021 Plastic Ophthalmic Drape APERTURE
• 10380651020204: Eye Pak* 1020 Plastic Ophthalmic Drape INCISE
• 10380650029208: Eye Pak* 0029 Non Woven Opthalmic Drape INCISE POUCH
• 10380650026207: Eye Pak* 0026 Non Woven Opthalmic Drape APERTURE