← Back to catalogue

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

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 10740

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, Improved Narrow, Rolled EUDAMED
Latex, 1"D x 8"L, Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal, Seamless, Straight, Improved Narrow, Rolled FDA UDI
Model / Reference
10740 EUDAMEDFDA UDI
Description
Latex, 1"D x 8"L, Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal, Seamless, Straight, Improved Narrow, Rolled FDA UDI

Identifiers

Primary DI / UDI-DI
D-10740SHEATHESC6 EUDAMED
10842418100203 FDA UDI
Basic UDI-DI
B-10740SHEATHESC6 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 04b83e80-335f-4686-99cc-eaa19420ca8f 61 fields · synced Jul 12, 2026
  • FDA UDI c5bcaf85-e557-4b5f-b50e-2c6bd6a0dd06 34 fields · synced May 30, 2026