AccessGUDID - DEVICE: Contact glass Retina 145 L (07640132986501)

GUDID

Device Identifier (DI) Information

Brand Name: Contact glass Retina 145 L
Version or Model: Retina 145 L
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1006092
Company Name: Haag-Streit AG

Primary DI Number: 07640132986501
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 483467544 *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?
47946	Ophthalmic diagnostic condensing lens	An ophthalmic lens intended to be used during binocular indirect ophthalmoscopy and/or slit lamp examination to focus reflected light from the fundus of the eye. The lens is available in a variety of sizes and optical powers. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HJK	Lens, Contact, Polymethylmethacrylate, Diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K051103	000

Device Exempt from Premarket Submission: No 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: a7cc18e4-98ed-4af8-a96d-6cd0724f5644
Public Version Date: June 17, 2022
Public Version Number: 4
DI Record Publish Date: September 23, 2016