Identity
- Trade Name
- Seeker® FDA UDI
- Generic Name
- Vascular guide-catheter, single-use FDA UDI
- Device Name
- Seeker® Crossing Support Catheter 0.035" Guidewire compatible, 90cm FDA UDI
- Model / Reference
- SK9035M FDA UDI
- Description
- Seeker® Crossing Support Catheter 0.035" Guidewire compatible, 90cm FDA UDI
Identifiers
- Catalog Number
- SK9035M FDA UDI
- Primary DI / UDI-DI
- 00801741067952 FDA UDI
- FDA Product Code
- DQY FDA UDI
- GMDN Term
- Vascular guide-catheter, single-use 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
Category: Vascular guide-catheter, single-use
Seeker® by Bard Peripheral Vascular — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vascular guide-catheter, single-use.
- Launcher — MEDTRONIC, INC. · Class II
- Launcher™ — MEDTRONIC, INC. · Class II
- SHERPA NX BALANCED — MEDTRONIC, INC. · Class II
- Surefire Guiding Catheter — Surefire Medical, Inc. · Class II
- SHERPA NX BALANCED™ — MEDTRONIC, INC. · Class II
- Zebra — QApel Medical, Inc. · Class II
- Mach1™ — Boston Scientific · Class II
- SHERPA NX BALANCED — MEDTRONIC, 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bard Peripheral Vascular
Sources (1)
- FDA UDI c7e7fa6d-65db-4940-ac1b-c45e9b333990 36 fields · synced May 31, 2026