AccessGUDID - DEVICE: Grieshaber 27+ Alcon (07612717071384)

GUDID

Device Identifier (DI) Information

Brand Name: Grieshaber 27+ Alcon
Version or Model: 339.31
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Alcon Laboratories, Inc.

Primary DI Number: 07612717071384
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008018525 *Terms of Use

Device Description: 27+ Diathermy Probe, DSP

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
Ophthalmic electrosurgical probe	A sterile, hand-held, ophthalmic surgical instrument intended to be introduced through the eye surface to deliver radio-frequency current, in a bipolar configuration, from a system generator directly to ocular tissues for blood coagulation and/or tissue adhesion during ophthalmic surgery. It includes a distal bipolar electrode and may include a connection cable. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
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

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Needle Gauge: 27 Gauge

Device Record Status

Public Device Record Key: 193cf060-0a69-4137-95e0-de77108cb4b7
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: December 22, 2016