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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
LinkedIn
—
Facebook
—
Phone
—
PRRC Contact
Gretchen Olson
EUDAMED SRN
US-MF-000044559
FDA FEI Number
1000135740
DUNS Number
—

Catalogue (491)

Page 6 of 10
DeviceModel / ReferenceRegistriesClassStatus
Sheathes 5-80340
FDA UDI
Class IIActive
Sheathes3D 65-IL486-22110-3
FDA UDI
Class IIActive
Sheathes3D 73401
FDA UDI
Class IIActive
Sheathes3D ADH-5-IL726
FDA UDI
Class IIActive
Sheathes 5-305
FDA UDI
Class IIActive
Sheathes3D 70340VCI
FDA UDI
Class IIActive
Sheathes 25026
FDA UDI
Class IIActive
Sheathes3D ADH-3545-4
FDA UDI
Class IIActive
Sheathes 5-965
FDA UDI
Class IIActive
Sheathes ADH-5-246
FDA UDI
Class IIActive
Sheathes3D 5-IT964
FDA UDI
Class IIActive
SheathesISO 70339
FDA UDI
Class IIActive
Sheathes 5-357-586
FDA UDI
Class IIActive
Sheathes3D ADH-5-IL2445
FDA UDI
Class IIActive
Sheathes 50040-486
FDA UDI
Class IIActive
Sheathes 50040-961
FDA UDI
Class IIActive
Sheathes 50087-365
FDA UDI
Class IIActive
Sheathes3D ADH-5-83740
FDA UDI
Class IIActive
Sheathes 5-306
FDA UDI
Class IIActive
Sheathes3D 5-IL5845
FDA UDI
Class IIActive
Sheathes3D 83740
FDA UDI
Class IIActive
Sheathes 5-26364
FDA UDI
Class IIActive
Sheathes 50040-26484
FDA UDI
Class IIActive
Sheathes3D 5-IB965
FDA UDI
Class IIActive
Sheathes3D 80786
FDA UDI
Class IIActive
Sheathes3D 5-IK486
FDA UDI
Class IIActive
Sheathes3D 75339
FDA UDI
Class IIActive
Sheathes 50001-725
FDA UDI
Class IIActive
Sheathes3D 5-IH486
FDA UDI
Class IIActive
Sheathes Pre-Gelled 27690-PT
EUDAMEDFDA UDI
Class IIActive
Sheathes 5-963
FDA UDI
Class IIActive
Sheathes3D 5-1245-IH586
FDA UDI
Class IIActive
Sheathes3D 5-IL246
FDA UDI
Class IIActive
Sheathes3D 5-IR964
FDA UDI
Class IIActive
Sheathes3D ADH-5-80040
FDA UDI
Class IIActive
Sheathes 50040-3635
FDA UDI
Class IIActive
Sheathes 5-80340-36
FDA UDI
Class IIActive
Sheathes 26340
FDA UDI
Class IIActive
Sheathes 25080
FDA UDI
Class IIActive
Sheathes 5-42040
FDA UDI
Class IIActive
Sheathes 50001-364
FDA UDI
Class IIActive
Sheathes 50040-25364
FDA UDI
Class IIActive
Sheathes 50040-364NS
FDA UDI
Class IIActive
Sheathes3D 80586
FDA UDI
Class IIActive
Sheathes 10780
FDA UDI
Class IIActive
Sheathes 10586
FDA UDI
Class IIActive
Sheathes 50001-2435
FDA UDI
Class IIActive
Sheathes 25336
FDA UDI
Class IIActive
Sheathes 50001-585
FDA UDI
Class IIActive
Sheathes 5-5855
FDA UDI
Class IIActive

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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.

DateRecall No.ClassStatusReason
Nov 17, 2025Z-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.