FDA UDI
In Commercial Distribution
🇺🇸 United States
Medetz Surgical Instruments
DI: G223140617S0
·
Model: 14-0617-s
·
Medetz Surgical Instruments LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Medetz Surgical Instruments
- Primary DI
- G223140617S0
- Version / Model
- 14-0617-s
- Company Name
- Medetz Surgical Instruments LLC
- Labeler DUNS
- 876570990
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-17
- Public Version
- 1
- Public Version Date
- 2024-06-25
- Public Version Status
- New
- Public Device Record Key
- e5fd7591-d859-42d2-9469-13c6c0b2c71c
Device Description
Mackool/Cylindrical Spatula DBL-Ended with Short Handle, Mackool Phaco Chopper, Micro .38mm Ball Shaped Blunt tip with Interior Cutting Edge, Angled 10mm from bend to tip, / Cylindrical Spatula, .4 Blade Angled/Semi-Vaulted 11mm from bend to tip, Round Knurled Handle, 100mm Overall Length,
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
- No
- 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 |
|---|---|---|---|---|
| HNQ | Hook, Ophthalmic | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13120 | Ophthalmic surgical probe, reusable | A slender, rod-like, hand-held manual surgical instrument intended to be used during an ophthalmic procedure to explore, measure, and/or manipulate ocular tissues (e.g., retraction/manipulation of intraocular structures, lens nucleus splitting, removal of foreign bodies in the eye, LASIK flap lifting); it is neither intended to cut tissue nor hook muscles. It is available with a variety of tip shapes including blunt bulbous, hook and T-shape, and the shaft may be straight or bent; it is made of flexible or rigid metallic and/or synthetic polymer material. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G223140617S0 | HIBCC |
Customer Contacts
- Phone
- 8004205135
- [email protected]