AccessGUDID - DEVICE: ALGERBRUSH II CORNEAL RUST RING REMOVER BURR (00192896012639)

GUDID

Device Identifier (DI) Information

Brand Name: ALGERBRUSH II CORNEAL RUST RING REMOVER BURR
Version or Model: 11-4610
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11-4610
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: 00192896012639
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: ALGERBRUSH II CORNEAL RUST RING REMOVER BURR ONLY

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:	No
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?
16413	Corneal bur, rust ring removal, reusable	A small shaft made of a hard metal (e.g., steel) with fluting or cutting planes designed for gentle removal ("brushing") of rust stains (rust rings) from the cornea after the extraction of a ferrous foreign object. It is attached to the tip of a special slow-rotation powered ophthalmic handpiece. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OHW	Burr, Corneal, Battery Powered, Rust Ring Removal

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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Dry Heat Sterilization
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 0.5 Millimeter Tip

Device Record Status

Public Device Record Key: 1e68f58f-2e99-484c-afc1-ea945188bdda
Public Version Date: April 10, 2025
Public Version Number: 4
DI Record Publish Date: September 18, 2018