FDA UDI
In Commercial Distribution
🇺🇸 United States
Ahmed™ Glaucoma Valve
DI: 00892064002188
·
Model: TE
·
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
- 00892064002188
- Version / Model
- TE
- Catalog Number
- TE
- Company Name
- NEW WORLD MEDICAL, INCORPORATED
- Labeler DUNS
- 622768711
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-12
- Public Version
- 3
- Public Version Date
- 2021-08-24
- Public Version Status
- Update
- Public Device Record Key
- 790e3515-166e-4f94-87f3-b700319dde91
Device Description
Ahmed Accessory Tube Extender
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 |
|---|---|---|---|---|
| 61127 | Glaucoma shunt | A non-bioabsorbable, implantable ocular device intended to create an artificial drainage channel for diversion of aqueous humour from the anterior chamber of the eye to reduce intraocular pressure (IOP) as an alternative to, or after failed, trabeculectomy, for the management of uncontrolled glaucoma. It consists of a tube which is introduced into the aqueous body (typically via limbal entry) and a distal episcleral plate intended to support a reservoir of aqueous humour; the shunt does not contain a valve. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00892064002188 | GS1 |
Customer Contacts
- Phone
- +1(909)466-4304
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K162060 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 4.8 | Millimeter | |
| Width | 3 | Millimeter |