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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 10 of 10

Device	Model / Reference	Registries	Class	Status
Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Rolled	50040-IH486	EUDAMEDFDA UDI	Class IIa	Active
Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal, Tapered, Rolled, Extra-Long	25340	EUDAMEDFDA UDI	Class I	Active
Sheathesiso Ultrasound Transducer Cover	K091828	FDA 510(k)	Class II	Active
Sheathes Needle Guide, Model Ng-Sr-A-484-Kit (there Will Be Various Model Numbers Based On Transducer And Cover)	K043425	FDA 510(k)	Class II	Active
Sheathes Ultrasond Gel	K112827	FDA 510(k)	Class II	Active
Sheathes Sterile Ultrasound Gel	K130041	FDA 510(k)	Class II	Active
Colonoscope/Sigmoidoscope Sheathes	K100966	FDA 510(k)	Class II	Active
Sheathes Ultrasound Probe Covers	K153212	FDA 510(k)	Class II	Active
Sheathes (non-Latex), Sterile	K990175	FDA 510(k)	Class II	Active
Sterile, Specialty Ultrasound Probe Cover with 2 Elastics, Rolled	80740	EUDAMEDFDA UDI	Class I	Active
Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal, Tapered, Rolled with Pull Tab, Extra-Long	26840	EUDAMEDFDA UDI	Class I	Active
Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal, Tapered, Rolled with Pull Tab, Extra-Long	26840 (ITL)	EUDAMED	Class I	Active
Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal, Seamless, Straight, Rolled, Extra-Long	10340 (ITL)	EUDAMED	Class I	Active
Sterile, Ultrasound Probe Cover with 2 Elastics, Semi-Rolled on Paper-Back	30340	EUDAMEDFDA UDI	Class I	Active
Sterile, Specialty Ultrasound Probe Cover with 2 Elastics, Rolled	80540	EUDAMEDFDA UDI	Class I	Active
Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Rolled	50040-366	EUDAMEDFDA UDI	Class IIa	Active
Sterile, Ultrasound Probe Cover with 2 Elastics, Semi-Rolled on Paper-Back	30340 (ITL)	EUDAMED	Class I	Active
Sterile, Ultrasound Probe Cover with 2 Elastics, Rolled	35340	EUDAMEDFDA UDI	Class I	Active
Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal, Seamless, Straight, Narrow, Rolled	10540 (ITL)	EUDAMED	Class I	Active
Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal, Seamless, Straight, Rolled	10040 (ITL)	EUDAMED	Class I	Active
Sterile Ultrasound Gel Pack	60001	EUDAMEDFDA UDI	Class I	Active
Sterile, Ultrasound Probe Cover with 2 Elastics, Semi-Rolled on Paper-Back	30740	EUDAMEDFDA UDI	Class I	Active
Sterile, Ultrasound Probe Cover with 3" Debris Shield and 1 Elastic, Vaginal/Rectal, Tapered, Bi-Directionally Rolled	40040	EUDAMEDFDA UDI	Class I	Active
Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal, Seamless, Straight, Rolled	10040	EUDAMEDFDA UDI	Class I	Active
Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal, Seamless, Straight, Rolled, Extra-Long	70340	EUDAMEDFDA UDI	Class I	Active
Sterile, Specialty Ultrasound Probe Cover with 2 Elastics, Rolled	80340	EUDAMEDFDA UDI	Class I	Active
Sterile, Specialty Ultrasound Probe Cover with 2 Elastics, Rolled	80040	EUDAMEDFDA UDI	Class I	Active
Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal, Seamless, Straight, Narrow, Rolled	10540	EUDAMEDFDA UDI	Class I	Active
Sterile, Ultrasound Probe Cover with 2 Elastics, Rolled	35740	EUDAMEDFDA UDI	Class I	Active
Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Rolled	50040-304	EUDAMEDFDA UDI	Class IIa	Active
Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Rolled	50040-366 (ITL)	EUDAMED	Class IIa	Active
Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal, Seamless, Straight, Improved Narrow, Rolled	10740 (ITL)	EUDAMED	Class I	Active
Ultrasound Gel Pack, Overwrapped Sterilized Chevron Pouch	60400	EUDAMEDFDA UDI	Class I	Active
Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal, Seamless, Straight, Rolled, Extra-Long	10340	EUDAMEDFDA UDI	Class I	Active
Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Intraoperative, Custom Tip, Rolled	50040-241CT	EUDAMEDFDA UDI	Class IIa	Active
Sterile, Ultrasound Probe Cover with 2 Elastics, Semi-Rolled on Paper-Back	30740 (ITL)	EUDAMED	Class I	Active
Sterile, Ultrasound Probe Cover with 3" Debris Shield and 1 Elastic, Vaginal/Rectal, Straight, Bi-Directionally Rolled	75440	EUDAMEDFDA UDI	Class I	Active
Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal, Seamless, Straight, Improved Narrow, Rolled	10740	EUDAMEDFDA UDI	Class I	Active
Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Rolled	50040-304 (ITL)	EUDAMEDFDA UDI	Class IIa	Active
Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Rolled	50040-245	EUDAMEDFDA UDI	Class IIa	Active
Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal, Straight, Narrow, Rolled, Extra-Long	75340	EUDAMEDFDA UDI	Class I	Active

Related Companies

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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.