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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 1 of 10

Device	Model / Reference	Registries	Class	Status
Sterile, Ultrasound Probe Cover with 20ml Sterile Gel & 1 Elastic, Vaginal/Rectal, Seamless, Straight, Rolled	5-70340 KIT	EUDAMED	Class I	Active
Sterile, Ultrasound Probe Cover with 20ml Sterile Gel & 1 Elastic, Vaginal/Rectal, Seamless, Straight, Rolled	5-10040 KIT	EUDAMED	Class I	Active
Sterile, Specialty Ultrasound Probe Cover with 20ml Sterile Gel & 2 Elastics, Rolled	5-80340 KIT	EUDAMED	Class I	Active
Sterile, Specialty Ultrasound Probe Cover with 20ml Sterile Gel & 2 Elastics, Semi-Rolled on Paper-Back	5-30340 KIT (ITL)	EUDAMED	Class I	Active
Sterile, Specialty Ultrasound Probe Cover with 20ml Sterile Gel & 2 Elastics, Semi-Rolled on Paper-Back	5-30340 KIT	EUDAMED	Class I	Active
Ultrashcallsondenabdeckung	ADH-5-IL4845 KIT	EUDAMED	Class IIa	Active
Ultrashcallsondenabdeckung	5-961 KIT	EUDAMED	Class IIa	Active
Ultrashcallsondenabdeckung	5-966 KIT	EUDAMED	Class IIa	Active
Sterile, Ultrasound Probe Cover Gathered on Applicator Tube with 3 Elastics, 20ml Sterile Gel, Bite Block, & 2 Tape Strips	5-T4040 KIT (ITL)	EUDAMED	Class IIa	Active
Sterile, Ultrasound Probe Cover with 20ml Sterile Gel & 1 Elastic, Vaginal/Rectal, Tapered, Rolled	5-25340 KIT	EUDAMED	Class I	Active
Sterile, Extended Field Ultrasound Probe & Cord Cover with 20ml Sterile Gel & 2 Elastics, Rolled	5-245 KIT (ITL)	EUDAMED	Class IIa	Active
Sterile, Extended Field Ultrasound Probe & Cord Cover with 20ml Sterile Gel & 2 Elastics, Rolled	5-2445T KIT	EUDAMED	Class IIa	Active
Sterile, Extended Field Ultrasound Probe & Cord Cover with 20ml Sterile Gel & 2 Elastics, Folded	5-IA964 KIT (ITL)	EUDAMED	Class IIa	Active
Sterile, Extended Field Ultrasound Probe & Cord Cover with 20ml Sterile Gel & 2 Elastics, Rolled	5-365 KIT	EUDAMED	Class IIa	Active
Sterile, Extended Field Ultrasound Probe & Cord Cover with 20ml Sterile Gel & 2 Elastics, Rolled	5-3635 KIT	EUDAMED	Class IIa	Active
Sterile, Extended Field Ultrasound Probe & Cord Cover with 20ml Sterile Gel & 2 Elastics, Telescopically Folded	5-964 KIT	EUDAMED	Class IIa	Active
Sterile, Extended Field Ultrasound Probe & Cord Cover with 20ml Sterile Gel & 2 Elastics, Intraoperative, Custom Tip, Rolled	5-241CT KIT	EUDAMED	Class IIa	Active
Sterile, Extended Field Ultrasound Probe & Cord Cover with 20ml Sterile Gel & 2 Elastics, Rolled	5-585 KIT	EUDAMED	Class IIa	Active
Sheathes3D	5-IA966	FDA UDI	Class II	Active
Sheathes	5-357-486	FDA UDI	Class II	Active
Sheathes	5-485	FDA UDI	Class II	Active
Sheathes	50040-484	FDA UDI	Class II	Active
Sheathes3D	ADH-5-35	FDA UDI	Class II	Active
Sheathes	40540	FDA UDI	Class II	Active
Sheathes	65-IL966-22110-3	FDA UDI	Class II	Active
Sheathes3D	5-1245-IL586	FDA UDI	Class II	Active
Sheathes	25086	FDA UDI	Class II	Active
Sheathes	10700	FDA UDI	Class II	Active
Sheathes3D	50040-IT964	FDA UDI	Class II	Active
Sheathes	26339VCI	FDA UDI	Class II	Active
Sheathes	5-484	FDA UDI	Class II	Active
Sheathes	25040	FDA UDI	Class II	Active
Sheathes	50001-3035	FDA UDI	Class II	Active
Sheathes Pre-Gelled	27680	FDA UDI	Class II	Active
Sheathes	5-10340	FDA UDI	Class II	Active
Sheathes3D	50001-IL246NS	FDA UDI	Class II	Active
Sheathes	65-486-12110-3	FDA UDI	Class II	Active
Sheathes3D Pre-Gelled	77380-PT	FDA UDI	Class II	Active
Sheathes	10086	FDA UDI	Class II	Active
Sheathes3D	50040-IT966	FDA UDI	Class II	Active
Sheathes	5-486	FDA UDI	Class II	Active
Sheathes Pre-Gelled	27380	FDA UDI	Class II	Active
Sheathes	25339	FDA UDI	Class II	Active
Sheathes3D	ADH-35-EL	FDA UDI	Class II	Active
Sheathes3D	5-IT966	FDA UDI	Class II	Active
Sheathes3D	73440	FDA UDI	Class II	Active
Sheathes	5-2435	FDA UDI	Class II	Active
Sheathes	51-484	FDA UDI	Class II	Active
Sheathes	26801	FDA UDI	Class II	Active
Sheathes	50001-965	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

MDSS GmbH DE

Importers

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Notified Bodies

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Authorities

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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.