AccessGUDID - DEVICE: Grieshaber 27+ Alcon (07612717071384)

GUDID

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

Primary DI Number: 07612717071384
Issuing Agency: GS1
Device Count: 1

Device Description: 27+ Diathermy Probe, DSP

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 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.

Product Code	Product Code Name
HQC	Unit, Phacofragmentation

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling
No storage/handling found

Size Type Text
Needle Gauge: 27 Gauge

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: December 22, 2016
Commercial Distribution End Date:

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
17612717071381	6	07612717071384		In Commercial Distribution	Box

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

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Device Subject to Direct Marking (DM), but Exempt: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Phone: +18008625266
Email: Web.masterus@alcon.com