Primary Device ID | 00380657517558 |
NIH Device Record Key | 1a56555b-596d-4d45-93f9-ab8eadc44d38 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Intrepid, AutoSert |
Version Model Number | 8065751755 |
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 | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
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 |
Phone | +1(800)862-5266 |
web.masterus@alcon.com | |
Phone | +1(800)862-5266 |
web.masterus@alcon.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00380657517558 [Primary] |
HQE | Instrument, vitreous aspiration and cutting, ac-powered |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00380657517558]
Moist Heat or Steam Sterilization
[00380657517558]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2017-06-07 |
10380657530660 - UNIPURE & UNIFEYE | 2024-11-05 UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System. Intraocular Gas Delivery System intended to treat uncomplicated |
10380657530677 - UNIPURE & UNIFEYE | 2024-11-05 UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System. Intraocular Gas Delivery System intended to treat uncomplicated |
10380657530684 - UNIPURE & UNIPEXY | 2024-11-05 UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery System. Intraocular Gas Delivery System intended to treat uncomplicated |
10380657530691 - UNIPURE & UNIPEXY | 2024-11-05 UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery System. Intraocular Gas Delivery System intended to treat uncomplicated r |
17612717072098 - FINESSE ModifEYE | 2024-10-04 25G ModifEYE Soft Tip Backflush - Long |
17612717072104 - FINESSE ModifEYE | 2024-10-04 27+ ModifEYE Soft Tip Backflush - Long |
17612717072067 - FINESSE ModifEYE | 2024-10-03 25G ModifEYE Soft Tip Backflush |
17612717072074 - FINESSE ModifEYE | 2024-10-03 27+ ModifEYE Soft Tip Backflush |