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Halo One™ Thin-Walled Guiding Sheath

FDA UDI

Class II (US FDA UDI)

by ClearStream Technologies , Ltd.

Identity

Trade Name
Halo One™ Thin-Walled Guiding Sheath FDA UDI
Generic Name
Vascular guide-catheter, single-use FDA UDI
Device Name
4F guiding sheath diameter, 10 cm shaft length, including 018 Dilator FDA UDI
Model / Reference
HLO41018 FDA UDI
Description
4F guiding sheath diameter, 10 cm shaft length, including 018 Dilator FDA UDI

Identifiers

Catalog Number
HLO41018 FDA UDI
Primary DI / UDI-DI
00801741161797 FDA UDI
510(k) Number
K192313 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

Yes

FDA UDI

Halo One™ Thin-Walled Guiding Sheath by ClearStream Technologies , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K192313 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
ClearStream Technologies , Ltd.

Sources (1)

  • FDA UDI e8e5f892-5a93-4ebf-a820-058ceed14747 37 fields · synced May 30, 2026