FDA UDI
In Commercial Distribution
🇺🇸 United States
Ahmed™ Glaucoma Valve
DI: 00892064002119
·
Model: FP7
·
NEW WORLD MEDICAL, INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Ahmed™ Glaucoma Valve
- Primary DI
- 00892064002119
- Version / Model
- FP7
- Catalog Number
- FP7
- Company Name
- NEW WORLD MEDICAL, INCORPORATED
- Labeler DUNS
- 622768711
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-16
- Public Version
- 6
- Public Version Date
- 2023-10-25
- Public Version Status
- Update
- Public Device Record Key
- d8fc5f06-faad-4aa8-bcd0-6fdd949db073
Device Description
Silicone Glaucoma Drainage Device
Device Characteristics
- Single Use
- Yes
- 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
- MR Safe
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KYF | IMPLANT, EYE VALVE | Ophthalmic | 886.3920 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42526 | Eye valve | A sterile device designed to regulate the flow of fluid between the anterior chamber and the space around the conjunctiva of the eye by allowing flow when the pressure in the chamber is above a pre-set value (e.g., 8 to 10 mmHg). It is typically a very small (e.g., slit) valve implanted in the eye as a component of an eye stent, and typically used in patients with advanced glaucoma when, despite the use of medication, laser treatments, or a previous glaucoma filtration procedure (trabeculectomy), the addition of a drainage tube and valve (aqueous shunt) is recommended. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00892064002119 | GS1 |
Customer Contacts
- Phone
- +1(909)466-4304
- [email protected]
Premarket Submissions
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Area/Surface Area | 184 | Square millimeter |