AccessGUDID - DEVICE: Alcon, TurboSonics, Flared ABS, MicroTip (00380657408399)

GUDID

Device Identifier (DI) Information

Brand Name: Alcon, TurboSonics, Flared ABS, MicroTip
Version or Model: 8065740839
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Alcon Laboratories, Inc.

Primary DI Number: 00380657408399
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 008018525 *Terms of Use

Device Description: 30° Kelman®, 0.9 mm TurboSonics® Flared ABS® MicroTip™ Tip

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?
36215	Phacoemulsification system handpiece tip, single-use	A device that is attached to a dedicated handpiece for insertion into the eye to deliver energy (e.g., ultrasonic, piezoelectric), provided from a system generator, to perform phacoemulsification (a procedure for the liquefying and removal of the opaque lens nucleus in cataract surgery). It may facilitate, via the handpiece, the irrigation/suction needed for the removal of debris. This is a single-use device.	Active	false

FDA Product Code

[?]

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
Angle: 30 degree
Outer Diameter: 0.9 Millimeter

Device Record Status

Public Device Record Key: fc1c22e5-9450-4435-b2bc-396eece580b6
Public Version Date: March 22, 2024
Public Version Number: 3
DI Record Publish Date: September 24, 2016