Identity
- Trade Name
- Agilis HisPro™ FDA UDI
- Generic Name
- Intravascular catheter slitter FDA UDI
- Device Name
- Slitter FDA UDI
- Model / Reference
- DS3A001 FDA UDI
- Description
- Slitter FDA UDI
Identifiers
- Catalog Number
- DS3A001 FDA UDI
- Primary DI / UDI-DI
- 05415067035028 FDA UDI
- FDA Product Code
- DWS FDA UDI
- GMDN Term
- Intravascular catheter slitter FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 870.4500 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Category: Intravascular catheter slitter
Agilis HisPro™ by St. Jude Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intravascular catheter slitter.
- ScoutPro Slitter Tool Advanced — BIOTRONIK SE & Co. KG · Class II
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- Worley™ Slitter — Merit Medical · Class I
- CPS™ — ST. JUDE MEDICAL, INC. · Class II
- CPS™ — ST. JUDE MEDICAL, INC. · Class I
- CPS 3D Plus — ST. JUDE MEDICAL, INC. · Class I
- CPS™ — ST. JUDE MEDICAL, INC. · Class II
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 I | Pending data |
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Manufacturer
- Manufacturer
- St. Jude Medical, Inc.
Sources (1)
- FDA UDI 95d654b5-f457-4224-8fc1-a837ab272493 36 fields · synced May 30, 2026