AccessGUDID - DEVICE: Irrigating Cystotome Formed 27G x 16mm (08052276012937)

GUDID

Device Identifier (DI) Information

Brand Name: Irrigating Cystotome Formed 27G x 16mm
Version or Model: 5008
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5008
Company Name: AKTIVE SRL

Primary DI Number: 08052276012937
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 433533053 *Terms of Use

Device Description: Irrigating Cystotome Formed 27G x 16mm

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:	Yes
Prescription Use (Rx):	No
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?
47007	Ophthalmic surgical irrigation/infusion/aspiration handle, single-use	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 single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HNY	Cystotome

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
Storage Environment Temperature: between 5 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: GAUGE

Device Record Status

Public Device Record Key: abf16a21-8909-47af-a766-706a4dcbc6e3
Public Version Date: December 27, 2023
Public Version Number: 1
DI Record Publish Date: December 19, 2023