FDA UDI
In Commercial Distribution
🇺🇸 United States
Medetz Surgical Instruments
DI: G2231196790
·
Model: 11-9679
·
Medetz Surgical Instruments LLC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Medetz Surgical Instruments
- Primary DI
- G2231196790
- Version / Model
- 11-9679
- Company Name
- Medetz Surgical Instruments LLC
- Labeler DUNS
- 876570990
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-11
- Public Version
- 1
- Public Version Date
- 2025-08-19
- Public Version Status
- New
- Public Device Record Key
- 9307c2d4-9a10-4ba0-b988-1710c62db356
Device Description
Meyerhoffer chalazion curette, 4 7/8", straight shaft with size # 0, 1.5mm cup, flat handle
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 |
|---|---|---|---|---|
| HNZ | Curette, Ophthalmic | Ophthalmic | 886.4350 | 1 |
| HNQ | Hook, Ophthalmic | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32772 | Ophthalmic curette, reusable | A hand-held, manual, ophthalmic surgical instrument typically with a fenestrated, spoon-shaped or ring-like tip which can be either sharp or blunt, intended to be used to obtain or remove eye tissue through a scraping action. It is typically made of metal. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G2231196790 | HIBCC |
Customer Contacts
- Phone
- 8004205135
- [email protected]