AccessGUDID - DEVICE: Alcon Grieshaber (07612717071124)

GUDID

Device Identifier (DI) Information

Brand Name: Alcon Grieshaber
Version or Model: 723.26
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Alcon Laboratories, Inc.

Primary DI Number: 07612717071124
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008018525 *Terms of Use

Device Description: Advanced DSP Tip MPC Vertical Scissors, 23G

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
Anterior/posterior segment scissors, single-use	An ophthalmic surgical instrument designed to cut either anterior or posterior segment tissue during eye surgery. It is typically: 1) two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed); or 2) an instrument tip, with cutting blades at the distal end, that is inserted into a dedicated handle through which the blades are operated. It is typically made of high-grade stainless steel and plastic materials, and is available in various sizes. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Anterior/posterior segment scissors, single-use

An ophthalmic surgical instrument designed to cut either anterior or posterior segment tissue during eye surgery. It is typically: 1) two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed); or 2) an instrument tip, with cutting blades at the distal end, that is inserted into a dedicated handle through which the blades are operated. It is typically made of high-grade stainless steel and plastic materials, and is available in various sizes. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered
HQC	Unit, Phacofragmentation

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

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
Needle Gauge: 23 Gauge

Device Record Status

Public Device Record Key: e1731198-8d38-4adb-b571-98c5fb93e2ba
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016