AccessGUDID - DEVICE: Alcon, INFINITECH (00380650112408)

GUDID

Device Identifier (DI) Information

Brand Name: Alcon, INFINITECH
Version or Model: 8065011240
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Alcon Laboratories, Inc.

Primary DI Number: 00380650112408
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 008018525 *Terms of Use

Device Description: High Pressure End Irrigating Endo Illuminator, Regular, 20Ga, 1.8m

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?
42572	Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use	A hand-held ophthalmic surgical instrument with a thin, rigid insertion portion designed to infuse, irrigate and/or aspirate the interior of the eye during a surgical procedure (e.g., cataract extraction), and simultaneously conduct, typically via a fibreoptic bundle, a field of cold light to illuminate the surgical site. It is connected to a light source (through a light cable) and to appropriate devices that provide the infusion/aspiration function. It is typically made of high-grade stainless steel and fibreoptic materials. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MPA	Endoilluminator

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
Device Size Text, specify: 20 Gauge
Length: 1.8 Meter

Device Record Status

Public Device Record Key: 288ad61a-05cf-441f-b05c-e03193339ed6
Public Version Date: March 21, 2024
Public Version Number: 5
DI Record Publish Date: September 24, 2016