FDA UDI
In Commercial Distribution
🇺🇸 United States
Diamatrix Ltd
DI: 00813059018243
·
Model: F645T
·
Diamatrix
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Diamatrix Ltd
- Primary DI
- 00813059018243
- Version / Model
- F645T
- Catalog Number
- F645T
- Company Name
- Diamatrix
- Labeler DUNS
- 809555139
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-05-17
- Public Version
- 1
- Public Version Date
- 2022-05-25
- Public Version Status
- New
- Public Device Record Key
- 7e83715e-dcb1-41a1-8124-b5fdf3ec6df5
Device Description
Kershner Capsulorrhexis Forceps, Thin Triangular Grasping tips, Angled 8mm from bend to tip, Diamond knurled handle with Flat, Guide pin stop for tip alignment, 102mm total length, Titanium
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
- No
- 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 |
|---|---|---|---|---|
| HNR | Forceps, Ophthalmic | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62674 | Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable | A hand-held manual surgical instrument designed to facilitate the grasping, manipulation, or clamping of, and/or removal of foreign bodies from, ophthalmic soft-tissues (ocular tissues, eyelids), and may be pointed for capsulorhexis. It has a conventional (self-opening) or reverse-action (self-closing) tweezers-like design with variously designed tips, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles); it is not probe-like in design (i.e., not cannulated). It is typically made of metal, available in various sizes, and may have carbide inserts at the working end. 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 | 00813059018243 | GS1 |