Identity
- Trade Name
- Halo One™ Thin-Walled Guiding Sheath FDA UDI
- Generic Name
- Vascular guide-catheter, single-use FDA UDI
- Device Name
- Halo One Thin-Walled Guiding Sheath 5F x 10cm FDA UDI
- Model / Reference
- HAL510F FDA UDI
- Description
- Halo One Thin-Walled Guiding Sheath 5F x 10cm FDA UDI
Identifiers
- Catalog Number
- HAL510F FDA UDI
- Primary DI / UDI-DI
- 00801741129698 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
- Not 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
Halo One™ Thin-Walled Guiding Sheath by ClearStream Technologies , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- ClearStream Technologies , Ltd.
Sources (1)
- FDA UDI 97e1d94b-6dc0-4b87-8b1c-42ad1244f9bd 37 fields · synced May 29, 2026