AccessGUDID - DEVICE: 55° Rotary microscissor 20G only Tip (08052276028044)

GUDID

Device Identifier (DI) Information

Brand Name: 55° Rotary microscissor 20G only Tip
Version or Model: AK-1651(S)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AK-1651(S)
Company Name: AKTIVE SRL

Primary DI Number: 08052276028044
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 433533053 *Terms of Use

Device Description: 55° Rotary microscissor 20G only Tip

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?
63722	Ophthalmic soft-tissue surgical forceps probe-tip, single-use	A sterile distal component of a probe-like ophthalmic soft-tissue surgical forceps assembly designed to grasp and manipulate intraocular tissues during ophthalmic surgery (e.g., anterior segment surgery, vitreo-retinal procedures, iridectomy, capsulorhexis). It is a probe-/cannula-like shaft with small grasping blades that protrude from the end of the shaft, and is intended to be attached to an appropriate ophthalmic surgical instrument handle (not included). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HNF	Scissors, 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
Device Size Text, specify: GAUGE

Device Record Status

Public Device Record Key: f6acb085-99f1-45a3-a5f7-595cac0e1923
Public Version Date: January 19, 2024
Public Version Number: 1
DI Record Publish Date: January 11, 2024