AccessGUDID - DEVICE: Disposable keratoscope (08717872007403)

GUDID

Device Identifier (DI) Information

Brand Name: Disposable keratoscope
Version or Model: 1420.D
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1420.D
Company Name: D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

Primary DI Number: 08717872007403
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 407522184 *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:	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?
62737	Keratoscope, non-powered, single-use	A non-powered, hand-held ophthalmic instrument intended for qualitative assessment of the curvature of the anterior surface of the cornea, typically to detect astigmatism during ophthalmic surgery (e.g., changes induced by sutures during corneal transplantation). Also referred to as a Maloney keratometer, it is in the form of a hollow cylinder or cone with internal concentric rings designed to be held on the cornea, whereby the distorted reflection of the rings on the corneal surface of the patient is indicative of astigmatism. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HJA	Photokeratoscope

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1d389b25-8aff-4639-941f-08c2514378bd
Public Version Date: September 22, 2023
Public Version Number: 1
DI Record Publish Date: September 14, 2023