FDA UDI
In Commercial Distribution
🇺🇸 United States
Medetz Surgical Instruments
DI: G2231132900
·
Model: 11-3290
·
Medetz Surgical Instruments LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Medetz Surgical Instruments
- Primary DI
- G2231132900
- Version / Model
- 11-3290
- Company Name
- Medetz Surgical Instruments LLC
- Labeler DUNS
- 876570990
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-10
- Public Version
- 2
- Public Version Date
- 2023-10-18
- Public Version Status
- Update
- Public Device Record Key
- e9dc6cc8-e151-472e-9a78-7b7eb896841e
Device Description
Aebli Corneal Section Scissor Left OL118mm(4 5/8")
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 |
|---|---|---|---|---|
| HNF | Scissors, Ophthalmic | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13486 | Corneal scissors, reusable | A hand-held, manual, ophthalmic surgical instrument intended to be used to cut corneal tissue (e.g., during cataract extraction surgery, corneal transplant surgery). It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically made of metal and is available in various designs and sizes; some designs may additionally be used for cutting sutures and drapes. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G2231132900 | HIBCC |
Customer Contacts
- Phone
- 8004205135
- [email protected]