Nagare SS8FMB74

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00861705000425 UDI-DI	Date29 May 2018Listed	StatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Nagare
Generic Name: Haemostasis valve
Model / Reference: SS8FMB74

Primary DI / UDI-DI: 00861705000425
FDA Product Code: DYB
GMDN Term: Haemostasis valve

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
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Class II

Properties

Sterile
Single Use
Prescription Use
Lot / Batch Number
Expiration Date

Other properties (9)

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