AccessGUDID - DEVICE: Retinal Scraper 20G Full Handle (08052276027085)

GUDID

Device Identifier (DI) Information

Brand Name: Retinal Scraper 20G Full Handle
Version or Model: AK-0509/S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AK-0509/S
Company Name: AKTIVE SRL

Primary DI Number: 08052276027085
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 433533053 *Terms of Use

Device Description: Retinal Scraper 20G Full Handle

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?
63432	Epiretinal/inner limiting membrane scraper, single-use	A hand-held manual surgical instrument intended to be used during posterior segment surgery to lift the inner limiting membrane (ILM) and/or an epiretinal membrane (ERM), and which may have additional posterior segment membrane manipulation uses. It includes a dedicated textured tip (e.g., diamond-dusted polymer) intended to effectively grip/lift the membrane for further manipulation (e.g., with forceps); it may additionally include non-powered features (e.g., fibreoptics) to allow cold light to be directed to the surgical site. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HND	Spatula, 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: 4ba3dc60-9bec-4a99-82f8-58c5ed9a219b
Public Version Date: January 19, 2024
Public Version Number: 1
DI Record Publish Date: January 11, 2024