AccessGUDID - DEVICE: Alcon Grieshaber (07612717071162)

GUDID

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Device Identifier (DI) Information

Brand Name: Alcon Grieshaber
Version or Model: 337.81
Catalog Number:
Company Name: Alcon Laboratories, Inc.

Primary DI Number: 07612717071162
Issuing Agency: GS1
Device Count: 1

Device Description: Advanced DSP Backflush Blunt, 20G

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
Vitrectomy fluid/gas handling instrument	A sterile, hand-held, manual, ophthalmic surgical instrument intended to handle fluids and gases during vitreoretinal surgery. It is used for controlling the extraction of fluids, the internal drainage of subretinal fluid, retinal fold manipulation [proliferative vitreoretinopathie (PVR), retinotomies, translocation], and simultaneous or sequential gas/fluid exchange [fluid-air, air-gas, fluid-gas, fluid-perfluorocarbon (PFC), PFC-gas]. It consists of a handle with a blunt or soft tip, that is inserted into the eye, and is equipped with tubing for aspiration and an integral backflush reservoir for retrograde flushing of incarcerated tissue during aspiration. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Vitrectomy fluid/gas handling instrument

A sterile, hand-held, manual, ophthalmic surgical instrument intended to handle fluids and gases during vitreoretinal surgery. It is used for controlling the extraction of fluids, the internal drainage of subretinal fluid, retinal fold manipulation [proliferative vitreoretinopathie (PVR), retinotomies, translocation], and simultaneous or sequential gas/fluid exchange [fluid-air, air-gas, fluid-gas, fluid-perfluorocarbon (PFC), PFC-gas]. It consists of a handle with a blunt or soft tip, that is inserted into the eye, and is equipped with tubing for aspiration and an integral backflush reservoir for retrograde flushing of incarcerated tissue during aspiration. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
HQC	Unit, Phacofragmentation

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: 20 Gauge

Device Status

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: September 24, 2016
Commercial Distribution End Date:

Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
17612717071169	6	07612717071162		In Commercial Distribution	Box

Secondary DI

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Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

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DEVICE: Alcon Grieshaber (07612717071162)