AccessGUDID - DEVICE: Amoils Epithelial Scrubber (00628693343046)

GUDID

Device Identifier (DI) Information

Brand Name: Amoils Epithelial Scrubber
Version or Model: Hyperopic Pack of 25
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AM1EX-HYPx
Company Name: Innova Medical Ophthalmics Inc

Primary DI Number: 00628693343046
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 249464702 *Terms of Use

Device Description: Amoils Epithelial Scrubber - Hyperopic Pack of 25

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):	Yes
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?
42443	Corneal bur system, battery-powered	An assembly of devices designed for abrasion of the cornea and other eye tissues. It typically consists of a small, battery-powered rotatory handpiece with a motor, and a small shaft made of a hard metal such as steel (i.e., a bur) that may include a diamond sphere at its tip. The system is used in procedures such as the gentle removal ("brushing") of rust stains (rust rings) from the cornea after the extraction of a ferrous foreign object, abrasion of the cornea to polish corneal scratches or the pterygium bed after surgical removal, and/or abrasion of lid margin lesions.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HOG	Burr, Corneal, Battery-Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K962989	000

Device Exempt from Premarket Submission: No 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 80dee940-d9f4-43b8-8c95-58f18ce51707
Public Version Date: December 09, 2022
Public Version Number: 1
DI Record Publish Date: December 01, 2022