AccessGUDID - DEVICE: MaxAC® Four Mirror Gonio Lens w/Small Ring 15mm (00630238095969)

GUDID

Device Identifier (DI) Information

Brand Name: MaxAC® Four Mirror Gonio Lens w/Small Ring 15mm
Version or Model: O4MAC-15
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OCULAR INSTRUMENTS, INC.

Primary DI Number: 00630238095969
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 046212387 *Terms of Use

Device Description: No description.

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?
11894	Gonioscope	A device intended to be used to examine the angle of the anterior chamber of the eye and for demonstrating ocular motility and rotation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HKS	Prism, Gonioscopic

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: cb9db234-6f84-4cfe-87fc-1f381ff6eb8f
Public Version Date: June 18, 2019
Public Version Number: 1
DI Record Publish Date: June 10, 2019