AccessGUDID - DEVICE: Clement Clarke Ophthalmic (05060179470375)

GUDID

Device Identifier (DI) Information

Brand Name: Clement Clarke Ophthalmic
Version or Model: 7006001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7006001
Company Name: HAAG-STREIT UK LIMITED

Primary DI Number: 05060179470375
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 296887714 *Terms of Use

Device Description: RAF BINOCULAR GAUGE

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":	Yes
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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Binocular vision test unit	An ophthalmic device for binocular vision testing. The patient views a four-dot light combination (1 white, 1 red and 2 green) through coloured glasses and informs the examining doctor when the combination perceived changes. This visual impression provides the information whereby a diagnosis of unconscious suppression of one eye can be determined.

FDA Product Code

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Product Code	Product Code Name
HLE	Ruler, Nearpoint (Punctometer)

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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: aa02e6ee-27f9-4c80-8ef9-bf0c288b00c6
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 05, 2016