AccessGUDID - DEVICE: Phaco Slit Knife 1.6 mm Dual Bevel Angled with protection (08052276033536)

GUDID

Device Identifier (DI) Information

Brand Name: Phaco Slit Knife 1.6 mm Dual Bevel Angled with protection
Version or Model: F-16/AP2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: F-16/AP2
Company Name: AKTIVE SRL

Primary DI Number: 08052276033536
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 433533053 *Terms of Use

Device Description: Phaco Slit Knife 1.6 mm Dual Bevel Angled with protection

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?
46741	Ophthalmic knife, single-use	A hand-held manual ophthalmic surgical instrument designed to make precise incisions in the eye and surrounding tissues during ophthalmic surgery. It is typically designed as a one-piece instrument with a sharp, single-edged cutting blade at the distal tip and a handle at the proximal end. It can have a variety of blade edge shapes, e.g., phaco (blunt or sharp), crescent, straight, and micro-phaco (for micro incision cataract surgery). It is usually made of high-grade stainless steel and some types can employ silicon (i.e., a brittle metalloid material) blades. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HNN	Knife, Ophthalmic

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
Length: 1.6 Millimeter

Device Record Status

Public Device Record Key: 1986c169-7243-490b-b808-288a5289e09c
Public Version Date: January 23, 2024
Public Version Number: 1
DI Record Publish Date: January 15, 2024