FDA UDI
In Commercial Distribution
🇺🇸 United States
Ahmed ClearPath ST
DI: 00892064002089
·
Model: ST250
·
NEW WORLD MEDICAL, INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Ahmed ClearPath ST
- Primary DI
- 00892064002089
- Version / Model
- ST250
- Catalog Number
- 10-0609
- Company Name
- NEW WORLD MEDICAL, INCORPORATED
- Labeler DUNS
- 622768711
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-18
- Public Version
- 3
- Public Version Date
- 2025-07-09
- Public Version Status
- Update
- Public Device Record Key
- f882af28-737c-4a76-adb4-22409342360c
Device Description
Glaucoma shunt
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 |
|---|---|---|---|---|
| 67548 | Glaucoma shunt, tubular, non-animal-derived | A non-bioabsorbable, implantable ocular tube, that does not include animal-derived materials, 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 is a metallic or synthetic polymer tube introduced into the anterior chamber (typically via limbal entry), that may include a distal episcleral plate intended to form a reservoir to facilitate drainage by the ocular tissues. Disposable devices associated with implantation may be packaged with the shunt. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00892064002089 | GS1 |
Customer Contacts
- Phone
- +1(909)466-4304
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Area/Surface Area | 250 | Square millimeter |