AccessGUDID - DEVICE: Tangible Clean (B673FG08230)

GUDID

Device Identifier (DI) Information

Brand Name: Tangible Clean
Version or Model: A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FG0823
Company Name: TANGIBLE SCIENCE, LLC

Primary DI Number: B673FG08230
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 968783071 *Terms of Use

Device Description: Tangible Clean is a multipurpose contact lens cleaner designed for use with gas permeable contact lenses, and is compatible for use with Tangible Hydra-PEG.

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):	Yes
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?
48074	Multi-purpose soft/rigid contact lens solution	A sterile aqueous formulation containing appropriate agents typically for cleaning, rinsing, protein removal, disinfecting, storing, and possibly wetting soft contact lenses and rigid gas permeable (RGP)/hard contact lenses. The solution may be specific to a type of procedure (e.g., manual, heated, or ultrasonic). After application, this device cannot be reused.	Active	false
48075	Multi-purpose rigid contact lens solution	A sterile aqueous formulation containing appropriate agents typically for cleaning, rinsing, protein removal, disinfecting, storing, and possibly wetting rigid gas permeable (RGP) and hard contact lenses. The solution may be specific to a type of procedure (e.g., manual, heated, or ultrasonic). After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MRC	Products, Contact Lens Care, Rigid Gas Permeable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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: 82f7e5f4-9054-4adc-a907-7be78de2fd9c
Public Version Date: December 17, 2019
Public Version Number: 2
DI Record Publish Date: November 01, 2018