AccessGUDID - DEVICE: Tangible Boost (B673FG6)

GUDID

Device Identifier (DI) Information

Brand Name: Tangible Boost
Version or Model: A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FG6
Company Name: TANGIBLE SCIENCE, LLC

Primary DI Number: B673FG6
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 968783071 *Terms of Use

Device Description: Tangible Boost is a monthly treatment to restore the Tangible Hydra-PEG® coating, and maintain the wettability of Tangible Hydra-PEG coated fluorosilicone acrylate rigid gas permeable lenses. Tangible Boost is intended for prescription (Rx) use only.

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?
60838	Contact lens rinsing solution	A sterile solution intended to be used to rinse debris or chemical agents from contact lenses (soft or rigid) prior to insertion; it may be intended to be used during storage or heat disinfection of contact lenses, or to dilute other contact lens solutions (e.g., contact lens protein-removal solution). It is an aqueous saline solution containing preservatives [e.g., edetate disodium (EDTA)] and buffering agents; it does not contain disinfecting, protein-removal, cleaning, or wetting agents. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QMM	Hydrophilic Re-Coating Solution

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN200002	000

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: 7d934724-03a7-44a2-bdad-ec6bba12d404
Public Version Date: February 09, 2021
Public Version Number: 1
DI Record Publish Date: February 01, 2021