AccessGUDID - DEVICE: ULTRA FLOW (00380658173012)

GUDID

Device Identifier (DI) Information

Brand Name: ULTRA FLOW
Version or Model: 00380658173012
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Alcon Laboratories, Inc.

Primary DI Number: 00380658173012
Issuing Agency: GS1
Commercial Distribution End Date: March 10, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 008018525 *Terms of Use

Device Description: ULTRAFLOW S/P 90 BENT TIP, .3 mm

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":	No
For Single-Use:	No
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?
63231	Ophthalmic surgical irrigation/infusion/aspiration handle, reusable	A hand-held, manual tubular device designed as an interface between an ophthalmic cannula intended for infusion, irrigation and/or aspiration (e.g., a capsular polishing or a cystotome cannula) and associated tubing, to facilitate manipulation of the cannula. It is typically made of metal or a durable polymer and is in the form a cylinder, that has a Luer fitting at the distal end, for connection to the cannula. It is typically used in cataract surgery. This is a reusable 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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 391574ee-b889-4a4f-b170-ba1857d72ff9
Public Version Date: March 27, 2024
Public Version Number: 5
DI Record Publish Date: March 09, 2018