FDA UDI
In Commercial Distribution
🇺🇸 United States
Infusion Handle
DI: G2231120000
·
Model: 11-2000
·
Medetz Surgical Instruments LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Infusion Handle
- Primary DI
- G2231120000
- Version / Model
- 11-2000
- Company Name
- Medetz Surgical Instruments LLC
- Labeler DUNS
- 876570990
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-03-22
- Public Version
- 2
- Public Version Date
- 2023-06-21
- Public Version Status
- Update
- Public Device Record Key
- fe063f99-71c7-46fc-9921-c7850c7f76de
Device Description
Infusion Handle, Plastic , Male to Female connector, 3.5 Inches Overall Length, Plastic
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 |
|---|---|---|---|---|
| KYG | Device, Irrigation, Ocular Surgery | Ophthalmic | 886.4360 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63231 | Ophthalmic surgical irrigation/infusion/aspiration handle, reusable | A hand-held, manual tubular device designed as an interface between an ophthalmic cannula intended for infusion, irrigation and/or aspiration (e.g., a capsular polishing or a cystotome cannula) and associated tubing, to facilitate manipulation of the cannula. It is typically made of metal or a durable polymer and is in the form a cylinder, that has a Luer fitting at the distal end, for connection to the cannula. It is typically used in cataract surgery. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G2231120000 | HIBCC |
Customer Contacts
- Phone
- 8004205135
- [email protected]