FDA UDI
In Commercial Distribution
🇺🇸 United States
MORIA
DI: 03700483606283
·
Model: Silicone block receptacle hollowed and pitted
·
MORIA SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MORIA
- Primary DI
- 03700483606283
- Version / Model
- Silicone block receptacle hollowed and pitted
- Catalog Number
- 17150B
- Company Name
- MORIA SA
- Labeler DUNS
- 275937506
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-15
- Public Version
- 1
- Public Version Date
- 2023-12-25
- Public Version Status
- New
- Public Device Record Key
- 7fb95bf7-6030-4e67-80f9-9bf13c2d7f8c
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HRH | Trephine, Manual, Ophthalmic | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64549 | Corneal punch base plate | A surgical device intended to be used as a platform onto which a donor cornea is placed to allow a precise circular section of the cornea (corneal button) to be cut from the cornea for subsequent transplantation into a prepared patient. It is a small base plate with a convex surface emulating the curvature of the eye; it does not include air pressure channels (i.e., not a corneal resection holder). It is designed to be used with a trephine and a guide (neither are included), whereby the section of corneal tissue is placed onto the centre of the base plate, the guide and trephine assembled into position, and the trephine pushed down to cut the button. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03700483606283 | GS1 |