Identity
- Trade Name
- Forté® AXP Access Sheath FDA UDI
- Generic Name
- Ureteral stent-placement set FDA UDI
- Device Name
- Ureteral Dilating Catheter FDA UDI
- Model / Reference
- B7286 FDA UDI
- Description
- Ureteral Dilating Catheter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00607915113537 FDA UDI
- FDA Product Code
- FED FDA UDI
- GMDN Term
- Ureteral stent-placement set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 55 Centimeter FDA UDI
Category: Ureteral stent-placement set
Forté® AXP Access Sheath by Applied Medical Resources Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Applied Medical Resources Corp.
Sources (1)
- FDA UDI d3a698da-a8bd-4738-8cc7-67403a31ac46 35 fields · synced May 30, 2026