← Back to catalogue

Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal, Seamless, Strai…

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 10340

by Sheathing Technologies, Inc.

Identity

Trade Name
Sheathes FDA UDI
Generic Name
Body-orifice ultrasound imaging transducer cover, basic FDA UDI
Device Name
Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal, Seamless, Straight, Rolled, Extra-Long EUDAMED
Latex, 1.18"D x 11.8"L, Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal, Seamless, Straight, Rolled, Extra-Long FDA UDI
Model / Reference
10340 EUDAMEDFDA UDI
Description
Latex, 1.18"D x 11.8"L, Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal, Seamless, Straight, Rolled, Extra-Long FDA UDI

Identifiers

Primary DI / UDI-DI
D-10340SHEATHES8A EUDAMED
10842418100128 FDA UDI
Basic UDI-DI
B-10340SHEATHES8A EUDAMED
510(k) Number
K925869 FDA UDI
FDA Product Code
ITX FDA UDI
EMDN Code
T030199 COVERS, INSTRUMENTS AND EQUIPMENT - OTHER EUDAMED
GMDN Term
Body-orifice ultrasound imaging transducer cover, basic FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
892.1570 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

Yes

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal, Seamless, Strai… by Sheathing Technologies, Inc. — Class I — MDD, FDA UDI — listed in EUDAMED…

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Sheathing Technologies, Inc.
EUDAMED SRN
US-MF-000044559
Authorised Representative
MDSS GmbH DE-AR-000005430

Sources (2)

  • EUDAMED 54968798-402e-4705-a2c6-39d6fd278535 61 fields · synced Jun 17, 2026
  • FDA UDI 21a0f47a-3b35-4ed3-b459-81ca34b51207 34 fields · synced May 29, 2026