DEVICE: Intrepid, AutoSert (00380657517558)

Device Identifier (DI) Information

Intrepid, AutoSert
8065751755
In Commercial Distribution

Alcon Laboratories, Inc.
00380657517558
GS1

1
008018525 *Terms of Use
Intrepid AutoSert IOL Injector
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
58160 Line-powered intraocular lens injector, reusable
A hand-held, direct current (DC) powered ophthalmic surgical instrument designed to expel (launch) a prepared folded intraocular lens (IOL) from an attached IOL insertion cartridge into the anterior chamber of the eye in association with cataract removal. It is a motorized device powered from a phacoemulsification system generator intended to carefully exert pressure on the prepared IOL to push it out of the IOL insertion cartridge. It is typically made of metallic and plastic materials and has a central plunger that is activated by a precise mechanism (e.g., a screw thread), and has a mechanism at the distal end to hold/grip the insertion cartridge. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
HQE Instrument, vitreous aspiration and cutting, ac-powered
HQC Unit, phacofragmentation
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

1a56555b-596d-4d45-93f9-ab8eadc44d38
March 29, 2018
2
June 07, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+1(800)862-5266
web.masterus@alcon.com
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