Identity
- Trade Name
- CHOCOLATE FDA UDI
- Generic Name
- Coronary angioplasty balloon catheter, basic FDA UDI
- Device Name
- Chocolate XD Hydro Coated 140cm 2.5x15 FDA UDI
- Model / Reference
- IPN914593 FDA UDI
- Description
- Chocolate XD Hydro Coated 140cm 2.5x15 FDA UDI
Identifiers
- Catalog Number
- CX14-140-2515 RX FDA UDI
- Primary DI / UDI-DI
- 10841156105440 FDA UDI
- FDA Product Code
- LOX FDA UDI
- GMDN Term
- Coronary angioplasty balloon catheter, basic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5100 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
No
FDA UDI
Over-the-Counter
Yes
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
Dimensions & Sizes
- Size
- Length — 15 Millimeter FDA UDIOuter Diameter — 2.5 Millimeter FDA UDI
Category: Coronary angioplasty balloon catheter, basic
Chocolate by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coronary angioplasty balloon catheter, basic.
- REBEL™ — Boston Scientific · Class III
- SPRINTER® LEGEND — MEDTRONIC, INC. · Class II
- NC STORMER® OTW — MEDTRONIC, INC. · Class II
- Pantera Pro — Biotronik, Inc. · Class II
- SPRINTER LEGEND — MEDTRONIC, INC. · Class II
- SPRINTER® LEGEND — MEDTRONIC, INC. · Class II
- SPRINTER LEGEND — MEDTRONIC, INC. · Class II
- Emerge™ — Boston Scientific · 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Teleflex Incorporated
Sources (1)
- FDA UDI 4a9686ce-7f45-42bb-9731-3b469a779fb3 36 fields · synced Jun 1, 2026