AccessGUDID - DEVICE: Full Handle Backflush 27G Soft tip Extensible Active/Passive (08052276026699)

GUDID

Device Identifier (DI) Information

Brand Name: Full Handle Backflush 27G Soft tip Extensible Active/Passive
Version or Model: AK-0465/AP-EX
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AK-0465/AP-EX
Company Name: AKTIVE SRL

Primary DI Number: 08052276026699
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 433533053 *Terms of Use

Device Description: Full Handle Backflush 27G Soft tip Extensible Active/Passive

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?
47130	Vitrectomy fluid/gas handling handpiece/cannula	A sterile, hand-held, invasive, ophthalmic surgical instrument intended to handle fluids and gases during vitreoretinal surgery. It is used for controlling the extraction of fluids, the internal drainage of subretinal fluid, retinal fold manipulation [proliferative vitreoretinopathie (PVR), retinotomies, translocation], and simultaneous or sequential gas/fluid exchange [fluid-air, air-gas, fluid-gas, fluid-perfluorocarbon (PFC), PFC-gas]. It consists of a handle with a blunt or soft tip/cannula, that is inserted into the eye, and may include aspiration tubing or an integral backflush reservoir for retrograde flushing of incarcerated tissue during aspiration. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KYG	Device, Irrigation, Ocular Surgery

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: 8e3376d5-1ad0-46e4-8a20-7e07215eb71c
Public Version Date: June 26, 2023
Public Version Number: 1
DI Record Publish Date: June 16, 2023