Is this your brand? Sign in to claim ownership.

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 3 of 10

Device	Model / Reference	Registries	Class	Status
Sheathes3D	5-357-IL486	FDA UDI	Class II	Active
Sheathes3D	ADH-5-80540	FDA UDI	Class II	Active
Sheathes	5-26840	FDA UDI	Class II	Active
SheathesISO	70303	FDA UDI	Class II	Active
Sheathes3D Pre-Gelled	77390-PT	FDA UDI	Class II	Active
Sheathes3D Pre-Gelled	77350	FDA UDI	Class II	Active
Sheathes3D	ADH-5-1245	FDA UDI	Class II	Active
Sheathes	5-361CT	FDA UDI	Class II	Active
Sheathes	26801VCI	FDA UDI	Class II	Active
Sheathes	5-26484	FDA UDI	Class II	Active
Sheathes	50001-123 ACP	FDA UDI	Class II	Active
Sheathes3D	83701	FDA UDI	Class II	Active
Sheathes3D Pre-Gelled	87780	FDA UDI	Class II	Active
Sheathes3D	50001-IL366	FDA UDI	Class II	Active
Sheathes3D	83501	FDA UDI	Class II	Active
Sheathes3D	ADH-50040-IL9645	FDA UDI	Class II	Active
Sheathes	50001-485	FDA UDI	Class II	Active
Sheathes3D	76401	FDA UDI	Class II	Active
Sheathes	50001-26964	FDA UDI	Class II	Active
Sheathes	10520	FDA UDI	Class II	Active
Sheathes	25320	FDA UDI	Class II	Active
Sheathes	5-45040	FDA UDI	Class II	Active
Sheathes3D	ADH-5-IL966	FDA UDI	Class II	Active
Sheathes	26840 24/Bag	FDA UDI	Class II	Active
Sheathes3D	5-1245-IH486	FDA UDI	Class II	Active
Sheathes3D	ADH-5-IL366	FDA UDI	Class II	Active
Sheathes	65-966-11815-3	FDA UDI	Class II	Active
Sheathes	50040-485	FDA UDI	Class II	Active
Sheathes3D	5-IA964	FDA UDI	Class II	Active
Sheathes3D	5-IL3645	FDA UDI	Class II	Active
Sheathes3D	ADH-50040-IL966	FDA UDI	Class II	Active
Sheathes3D	5-IH966	FDA UDI	Class II	Active
Sheathes3D	ADH-35-4	FDA UDI	Class II	Active
Sheathes3D	74339	FDA UDI	Class II	Active
Sheathes3D	5-IJ486	FDA UDI	Class II	Active
Sheathes	25080VCI	FDA UDI	Class II	Active
Sheathes	5-4835	FDA UDI	Class II	Active
Sheathes3D	5-IH966NS	FDA UDI	Class II	Active
Sheathes	50001-484	FDA UDI	Class II	Active
Sheathes	5-486NS	FDA UDI	Class II	Active
Sheathes3D Pre-Gelled	77890	FDA UDI	Class II	Active
Sheathes3D	ADH-5-IH966	FDA UDI	Class II	Active
Sheathes3D	ADH-5-IL4845	FDA UDI	Class II	Active
Sheathes	50001-3055	FDA UDI	Class II	Active
Sheathes	5-30340	FDA UDI	Class II	Active
Sheathes3D	5-IH366	FDA UDI	Class II	Active
Sheathes	5-304	FDA UDI	Class II	Active
Sheathes	10339	FDA UDI	Class II	Active
Sheathes	5-241CT	FDA UDI	Class II	Active
Sheathes3D	75480	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.