CrossWise CW-STS8F25

by Kalila Medical, Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00850021246082 UDI-DI	Date1 Feb 2022Listed	StatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: CrossWise
Generic Name: Vascular guide-catheter, single-use
Model / Reference: CW-STS8F25

Primary DI / UDI-DI: 00850021246082
FDA Product Code: DYB
GMDN Term: Vascular guide-catheter, single-use

Device Class: Class II
Regulation Number: 870.1340
GUDID distribution status: Not in Commercial Distribution

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Class II
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Class II
Vado Steerable Sheath

Class II

Properties

Sterile
Single Use
Prescription Use
Lot / Batch Number
Expiration Date
Manufacturing Date

Other properties (8)

Implantable: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No