Identity
- Trade Name
- ACUCISE® CUSTOM KIT FDA UDI
- Generic Name
- Polymeric ureteral stent FDA UDI
- Device Name
- Kit Contains: B1005, ACUCISE® ENDOPYELOTOMY SYSTEM B3304, STENT, C-FLEX 7/10F x 24 CM FDA UDI
- Model / Reference
- BK016 FDA UDI
- Description
- Kit Contains: B1005, ACUCISE® ENDOPYELOTOMY SYSTEM B3304, STENT, C-FLEX 7/10F x 24 CM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 30607915123056 FDA UDI
- FDA Product Code
- KNY FDA UDIEZB FDA UDIDXT FDA UDIEYB FDA UDI
- GMDN Term
- Polymeric ureteral stent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5130 FDA UDI870.1650 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Acucise® Custom Kit by Applied Medical Resources Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 46f5d5ca-a23a-4f93-a098-446036e0ceb3 35 fields · synced Jun 6, 2026