Identity
- Trade Name
- BeBack Crossing Catheter FDA UDI
- Generic Name
- Peripheral vascular intervention infusion catheter FDA UDI
- Device Name
- The BeBack Crossing Catheter is designed to address the needs of vascular interventionalists (Radiologists, Angiologists) and vascular surgeons when attempting to place a guidewire in the peripheral vasculature during endovascular procedures. The BeBack Crossing Catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions oft he peripheral vasculature. It may be used to facilitate placement and exchange of guidewires. The BeBack Crossing Catheter is available with outer diameters of 4 F (1.4 mm) or 2.9 F (0.96 mm), accommodate 0.018“ or 0.014“ guidewires accordingly, and both diameters have effective lengths of 80 cm or 120 cm. FDA UDI
- Model / Reference
- 4 F, 80 cm FDA UDI
- Description
- The BeBack Crossing Catheter is designed to address the needs of vascular interventionalists (Radiologists, Angiologists) and vascular surgeons when attempting to place a guidewire in the peripheral vasculature during endovascular procedures. The BeBack Crossing Catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions oft he peripheral vasculature. It may be used to facilitate placement and exchange of guidewires. The BeBack Crossing Catheter is available with outer diameters of 4 F (1.4 mm) or 2.9 F (0.96 mm), accommodate 0.018“ or 0.014“ guidewires accordingly, and both diameters have effective lengths of 80 cm or 120 cm. FDA UDI
Identifiers
- Catalog Number
- GB-600-US-018P-80L FDA UDI
- Primary DI / UDI-DI
- 04260279096470 FDA UDI
- 510(k) Number
- K211802 FDA UDI
- FDA Product Code
- PDU FDA UDI
- GMDN Term
- Peripheral vascular intervention infusion catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1250 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
- Introducer Sheath Compatibility — 4 French FDA UDICatheter Length — 80 Centimeter FDA UDI
Category: Peripheral vascular intervention infusion catheter
BeBack Crossing Catheter by Bentley InnoMed GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- Bentley InnoMed GmbH
Sources (1)
- FDA UDI 3e110f15-da97-49d5-a773-2c36e753bd51 38 fields · synced Jun 6, 2026