Identity
- Trade Name
- ARROW FDA UDI
- Generic Name
- Intravascular ultrasound imaging catheter, single-use FDA UDI
- Device Name
- VPS G4(TM) Device Stylet Extension Cable FDA UDI
- Model / Reference
- IPN035985 FDA UDI
- Description
- VPS G4(TM) Device Stylet Extension Cable FDA UDI
Identifiers
- Catalog Number
- VPS-G4SEC FDA UDI
- Primary DI / UDI-DI
- 00801902091857 FDA UDI
- 510(k) Number
- K123813 FDA UDI
- FDA Product Code
- OBJ FDA UDI
- GMDN Term
- Intravascular ultrasound imaging catheter, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1200 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
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
Category: Intravascular ultrasound imaging catheter, single-use
Arrow by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Intravascular ultrasound imaging catheter, single-use.
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- OptiCross™ 6 — Boston Scientific · Class II
- OptiCross™ HD — 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 |
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Manufacturer
- Manufacturer
- Teleflex Incorporated
Sources (1)
- FDA UDI 74f53275-dcf3-4248-8a07-9283b6937496 36 fields · synced May 30, 2026