AccessGUDID - DEVICE: Alcon Grieshaber REVOLUTION 25+ (07612717070691)

GUDID

Device Identifier (DI) Information

Brand Name: Alcon Grieshaber REVOLUTION 25+
Version or Model: 705.52P
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Alcon Laboratories, Inc.

Primary DI Number: 07612717070691
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008018525 *Terms of Use

Device Description: 25+® REVOLUTION DSP Curved Scissors

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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
63478	Intraocular scissors, probe-like, single-use	A sterile, hand-held, manual, ophthalmic surgical instrument intended to be used to cut intraocular tissue (e.g., during anterior chamber surgery, vitrectomy). As a complete instrument it comprises two shearing blades at the end of a probe-/cannula-like shaft with a proximal slimline handle, typically operated by squeezing. It is available with various blade designs and sizes. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HNF	SCISSORS, OPHTHALMIC

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
No Device Sizes

Device Record Status

Public Device Record Key: d3fd1317-29cf-4212-a856-f372ff7bf320
Public Version Date: August 26, 2020
Public Version Number: 1
DI Record Publish Date: August 18, 2020