Identity
- Trade Name
- ACUCISE® PROCEDURAL PACK UNIVERSAL PACK C FDA UDI
- Generic Name
- Ureteral stent-placement set FDA UDI
- Device Name
- Kit Contains: B1005, ACUCISE® ENDOPYELOTOMY SYSTEM B3304, STENT, C-FLEX 7/10F x 24 CM B7016, FORTE AxP SET 12/14/18F 35CM 6/BX FDA UDI
- Model / Reference
- BK004 FDA UDI
- Description
- Kit Contains: B1005, ACUCISE® ENDOPYELOTOMY SYSTEM B3304, STENT, C-FLEX 7/10F x 24 CM B7016, FORTE AxP SET 12/14/18F 35CM 6/BX FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20607915128146 FDA UDI
- FDA Product Code
- KNY FDA UDIEZB FDA UDIDXT FDA UDIEYB FDA UDIFED FDA UDIFAD FDA UDI
- GMDN Term
- Ureteral stent-placement set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5130 FDA UDI870.1650 FDA UDI876.1500 FDA UDI876.4620 FDA UDI
- Commercial Distribution
- Not 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
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® Procedural Pack Universal Pack C 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 5b30fdbe-0b5a-407c-91cc-4503f0b2b69a 35 fields · synced May 30, 2026