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Sheathing Technologies, Inc.

United States·US-MF-000044559

Last updated September 17, 2026

About

Sheathing Technologies, Inc. is headquartered in Morgan Hill, California. We offer the most extensive selection of medical probe cover sizes and shapes available.

From the manufacturer's own website. Source

Information

Country: United States
Address: 675 , Jarvis Drive, Morgan Hill, United States
Website: www.sheathes.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Gretchen Olson
EUDAMED SRN: US-MF-000044559
FDA FEI Number: 1000135740
DUNS Number: —

Catalogue (491)

Page 8 of 10

Device	Model / Reference	Registries	Class	Status
Sheathes	65-484-21815-3	FDA UDI	Class II	Active
Sheathes	65-485-12110-3	FDA UDI	Class II	Active
Sheathes	29320	FDA UDI	Class II	Active
Sheathes	25001	FDA UDI	Class II	Active
Sheathes3D	74080	EUDAMEDFDA UDI	Class II	Active
Sheathes	5-961CT	FDA UDI	Class II	Active
Sheathes	50040-965	FDA UDI	Class II	Active
Sheathes	10786	FDA UDI	Class II	Active
Sheathes	5-365	FDA UDI	Class II	Active
Sheathes	10500	FDA UDI	Class II	Active
Sheathes3D	80080	FDA UDI	Class II	Active
Sheathes3D	ADH-50001-1245	FDA UDI	Class II	Active
Sheathes	5-724	FDA UDI	Class II	Active
Sheathes	5-40040	FDA UDI	Class II	Active
Sheathes	40500	FDA UDI	Class II	Active
Sheathes	50001-25364	FDA UDI	Class II	Active
Sheathes Pre-Gelled	27080	FDA UDI	Class II	Active
Sheathes3D	50001-IL2445	FDA UDI	Class II	Active
Sheathes	ADH-5-486	FDA UDI	Class II	Active
Sheathes	42380	EUDAMEDFDA UDI	Class II	Active
Sheathes3D	5-1245-IL4845	FDA UDI	Class II	Active
Sheathes	50001-961CT	FDA UDI	Class II	Active
Sheathes3D Pre-Gelled	50001-77244	FDA UDI	Class II	Active
Sheathes	5-584NS	FDA UDI	Class II	Active
Sheathes	50040-2435	EUDAMEDFDA UDI	Class II	Active
Sheathes	40580	FDA UDI	Class II	Active
Sheathes3D	50040-IL246	FDA UDI	Class II	Active
Sheathes	50001-305	FDA UDI	Class II	Active
Sheathes	10080	FDA UDI	Class II	Active
Sheathes	65-486-21815-3	FDA UDI	Class II	Active
Sheathes3D	5-IK966	FDA UDI	Class II	Active
Sheathes	50040-585	FDA UDI	Class II	Active
Sheathes	50001-25484	FDA UDI	Class II	Active
Sheathes	50040-306	FDA UDI	Class II	Active
Sheathes	50001-963	FDA UDI	Class II	Active
Sheathes3D	ADH-5-80740	FDA UDI	Class II	Active
Sheathes	5-585	FDA UDI	Class II	Active
Sheathes	5-40540	FDA UDI	N/A	Active
Sheathes	50040-246NS	FDA UDI	Class II	Active
Sheathes3D	ADH-50040-IL4845	FDA UDI	Class II	Active
Sheathes3D	76480	FDA UDI	Class II	Active
Sheathes	5-25040	FDA UDI	Class II	Active
Sheathes	50040-3055	FDA UDI	Class II	Active
Sheathes	5-35740	FDA UDI	Class II	Active
Sheathes	26339	FDA UDI	Class II	Active
Sheathes	9-27380	FDA UDI	Class II	Active
Sheathes3D	ADH-5-IL486	FDA UDI	Class II	Active
Sheathes3D	76303	FDA UDI	Class II	Active
SheathesISO	70303VCI	FDA UDI	Class II	Active
Sheathes3D	73451	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

MDSS GmbH DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Nov 17, 2025	Z-1006-2026	—	open, classified	Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.