AccessGUDID - DEVICE: Alcon (00380657402595)

GUDID

Device Identifier (DI) Information

Brand Name: Alcon
Version or Model: 8065740259
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Alcon Laboratories, Inc.

Primary DI Number: 00380657402595
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008018525 *Terms of Use

Device Description: End Irrigating Fiber Optic, Regular, 20Ga, 2.1m

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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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.

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.

FDA Product Code

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Product Code	Product Code Name
MPA	Endoilluminator

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 20 Gauge
Length: 2.1 Meter

Device Record Status

Public Device Record Key: 8dbfa48c-a46e-484e-8152-4931e102e7f9
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016