FDA UDI
In Commercial Distribution
🇺🇸 United States
Tangible Clean
DI: 00198168983577
·
Model: A
·
TANGIBLE SCIENCE, INC.
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Tangible Clean
- Primary DI
- 00198168983577
- Version / Model
- A
- Catalog Number
- FG0823
- Company Name
- TANGIBLE SCIENCE, INC.
- Labeler DUNS
- 968783071
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-22
- Public Version
- 2
- Public Version Date
- 2026-04-17
- Public Version Status
- Update
- Public Device Record Key
- b3e6ab89-56fa-4c01-82d0-05934772fea4
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
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MRC | Products, Contact Lens Care, Rigid Gas Permeable | Ophthalmic | 886.5918 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00198168983577 | GS1 |
Customer Contacts
- Phone
- 18442603355
- [email protected]