AccessGUDID - DEVICE: Clement Clarke Ophthalmic (05060179470399)

GUDID

Device Identifier (DI) Information

Brand Name: Clement Clarke Ophthalmic
Version or Model: 7005001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7005001
Company Name: HAAG-STREIT UK LIMITED

Primary DI Number: 05060179470399
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 504108242 *Terms of Use

Device Description: MADDOX WING TEST

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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
32716	Maddox wing	A hand-held, non-powered ophthalmic device intended to evaluate heterophoria/heterotropia, also known as strabismus or squint [i.e., a condition in which the eyes are pointing in slightly different directions (e.g., esophoria, exophoria, hyperphoria and/or cyclophoria)]. It is typically held by the patient, and consists of an eyepiece oriented towards a small board with a scale(s) [e.g., horizontal, vertical] and pointer(s), and a thin sheet (septum) which separates the board into two parts to create a different field of view for each eye (eye dissociation).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HKW	Prism, Bar, 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: 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: fd4a6bea-3094-4797-9fa9-fcc0f7eef951
Public Version Date: November 09, 2023
Public Version Number: 4
DI Record Publish Date: August 12, 2016