Identity
- Trade Name
- SupraCross Steerable Sheath FDA UDI
- Generic Name
- Vascular guide-catheter, single-use FDA UDI
- Device Name
- SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire FDA UDI
- Model / Reference
- SSS0004 FDA UDI
- Description
- SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire FDA UDI
Identifiers
- Catalog Number
- NA FDA UDI
- Primary DI / UDI-DI
- 00685447005964 FDA UDI
- FDA Product Code
- DYB FDA UDI
- GMDN Term
- Vascular guide-catheter, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1340 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: Vascular guide-catheter, single-use
SupraCross Steerable Sheath by Baylis Médicale Cie Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vascular guide-catheter, single-use.
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- 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 |
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Manufacturer
- Manufacturer
- Baylis Médicale Cie Inc
Sources (1)
- FDA UDI 043b3e3a-2d65-47ff-b86f-60724dd87164 35 fields · synced May 31, 2026