Tangible Boost

Primary DI
B673FG6
Brand
Tangible Boost
Company
TANGIBLE SCIENCE, INC.
Model
A
Catalog number
FG6
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.
Published
2021-02-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QMMHydrophilic Re-Coating Solution

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QMMHydrophilic Re-Coating SolutionOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN200002000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN200002000Tangible BoostTangible Science, Inc.2020-09-24QMM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B673FG6PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Contact lens rinsing solutionA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18442603355info@tangiblescience.com

Regulatory Flags#

DUNS number
968783071
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198168596739Tangible Clean Sample BottleAFG08602024-04-22
00198168983577Tangible CleanAFG08232024-04-22
B673FG08230Tangible CleanAFG08232018-11-01
B673FG08233Tangible Clean 3-packAFG08232018-11-01
B673FG08600Tangible Clean Sample BottleAFG08602018-11-01