FDA UDI
In Commercial Distribution
🇺🇸 United States
MORIA
DI: 03700483605583
·
Model: Haptic Cutter
·
MORIA SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MORIA
- Primary DI
- 03700483605583
- Version / Model
- Haptic Cutter
- Catalog Number
- 19068
- Company Name
- MORIA SA
- Labeler DUNS
- 275937506
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-11
- Public Version
- 1
- Public Version Date
- 2023-12-19
- Public Version Status
- New
- Public Device Record Key
- ec9421e8-dfe1-47f3-a790-6c586b1fe850
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 |
|---|---|---|---|---|
| HNF | Scissors, Ophthalmic | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63482 | Intraocular lens removal scissors/cutter, probe-like | A hand-held, manual, ophthalmic surgical instrument intended to be used to cut an in situ intraocular lens (IOL) as part of IOL removal. It comprises a shearing blade(s) at the end of a probe-like shaft with a proximal slimline handle, typically operated by squeezing. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03700483605583 | GS1 |