FDA UDI
In Commercial Distribution
🇺🇸 United States
The Morgan medi-FLOW Lens
DI: M170MT20000
·
Model: MT2000
·
Mortan Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- The Morgan medi-FLOW Lens
- Primary DI
- M170MT20000
- Version / Model
- MT2000
- Company Name
- Mortan Inc.
- Labeler DUNS
- 057490781
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-13
- Public Version
- 3
- Public Version Date
- 2023-12-14
- Public Version Status
- Update
- Public Device Record Key
- 98415c76-5025-48a4-b3d7-8ef5dfaa170f
Device Description
Ocular irrigation system
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KYG | Device, irrigation, ocular surgery | Ophthalmic | 886.4360 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65415 | Eye irrigation shield, single-use | A device intended to be used with an eye irrigation kit/system to direct irrigation solution to the surface of the eye and allow the solution to gently lavage the surface of the eye (e.g., to flush the cornea and sclera of irritating particulates/chemicals). It is a curved/cup-like device, intended to be placed over the eye surface, with a port to allow entry of the irrigation solution; it may include a length of tubing. It is intended to be connected to an irrigation solution reservoir/pump. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M170MT20000 | HIBCC | ||||
| Package | M170MT20001 | HIBCC | Box | 12 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(406)728-2522
- [email protected]