DEVICE: Alcon, INFINITECH (00380650112408)

Device Identifier (DI) Information

Alcon, INFINITECH
8065011240
In Commercial Distribution

Alcon Laboratories, Inc.
00380650112408
GS1

1
008018525 *Terms of Use
High Pressure End Irrigating Endo Illuminator, Regular, 20Ga, 1.8m
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Device Characteristics

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

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Fibreoptic ophthalmic irrigation/aspiration cannula, single-use A sterile, hand-held ophthalmic surgical instrument with a thin, rigid insertion portion designed to irrigate and/or aspirate the interior of the eye during surgical procedures (e.g., cataract extraction), and simultaneously conduct, through an integrated fibreoptic bundle, a field of cold light to illuminate the surgical site. It is connected to a light source (through a light cable) and to appropriate devices that provide the irrigation/aspiration function. It is typically made of high-grade stainless steel and fibreoptic materials. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
MPA Endoilluminator
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FDA Premarket Submission

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

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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

[?]
Size Type Text
Device Size Text, specify: 20 Gauge
Length: 1.8 Meter
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Device Record Status

288ad61a-05cf-441f-b05c-e03193339ed6
March 29, 2018
2
September 24, 2016
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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
10380650112405 10 00380650112408 In Commercial Distribution Box
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Secondary DI

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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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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