AccessGUDID - DEVICE: Hoffer Optical Zone Marker, With Cross Hairs, 8.5mm, Titanium (08175700107150)

GUDID

Device Identifier (DI) Information

Brand Name: Hoffer Optical Zone Marker, With Cross Hairs, 8.5mm, Titanium
Version or Model: AS3-100T-8.5
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AS3-100T-8.5
Company Name: AURORA SURGICAL, LLC

Primary DI Number: 08175700107150
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 968368832 *Terms of Use

Device Description: Hoffer Optical Zone Marker, With Cross Hairs, 8.5mm, Titanium

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):	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?
63521	Ophthalmic angular gauge, reusable	A non-powered, hand-held, ophthalmic surgical device designed to measure angular distances radially around the surface of the eye [e.g., during intraocular lens (IOL) implantation/alignment]. Also referred to as a Mendez degree gauge, it consists of a handle with a distal ring which includes angle degree markings; it may include blunt teeth on the underside of the ring to allow it to grip to the eye during use. It is not intended for use as a marker. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HLF	Device, Measuring, Lens Radius, 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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: de573b76-19b4-420d-9515-ceb8fbebe527
Public Version Date: July 03, 2023
Public Version Number: 1
DI Record Publish Date: June 23, 2023