← Back to catalogue

Sterile, Ultrasound Probe Cover with 2 Elastics, Rolled

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 35340

by Sheathing Technologies, Inc.

Identity

Trade Name
Sheathes FDA UDI
Generic Name
Body-surface ultrasound imaging transducer cover FDA UDI
Device Name
Sterile, Ultrasound Probe Cover with 2 Elastics, Rolled EUDAMED
Polyurethane, 3.5"W x 12"L, Sterile, Ultrasound Probe Cover with 2 Elastics, Rolled FDA UDI
Model / Reference
35340 EUDAMEDFDA UDI
Description
Polyurethane, 3.5"W x 12"L, Sterile, Ultrasound Probe Cover with 2 Elastics, Rolled FDA UDI

Identifiers

Primary DI / UDI-DI
D-35340SHEATHESGM EUDAMED
10842418100531 FDA UDI
Basic UDI-DI
B-35340SHEATHESGM EUDAMED
510(k) Number
K990175 FDA UDI
FDA Product Code
ITX FDA UDI
EMDN Code
T030199 COVERS, INSTRUMENTS AND EQUIPMENT - OTHER EUDAMED
GMDN Term
Body-surface ultrasound imaging transducer cover 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

No

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 2 Elastics, Rolled by Sheathing Technologies, Inc. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID

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 51812911-ffa5-43a1-bdcc-7e122cacbfd6 61 fields · synced Jul 15, 2026
  • FDA UDI 10af7f9f-96ea-4ca6-acff-d5695fef337e 34 fields · synced May 30, 2026