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Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Rolled

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 50040-304 (ITL)Ref 50040-363

by Sheathing Technologies, Inc.

Identity

Trade Name
Sheathes FDA UDI
Generic Name
Body-surface ultrasound imaging transducer cover FDA UDI
Device Name
Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Rolled EUDAMED
Polyurethane, 3"W x 36"L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Rolled FDA UDI
Model / Reference
50040-304 (ITL) EUDAMED
50040-363 EUDAMEDFDA UDI
Description
Polyurethane, 3"W x 36"L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Rolled FDA UDI

Identifiers

Primary DI / UDI-DI
D-50040-304(ITL)AG EUDAMED
D-50040-363SHEATHES8F EUDAMED
10842418101750 FDA UDI
Basic UDI-DI
B-50040-304(ITL)AG EUDAMED
B-50040-363SHEATHES8F 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 IIa EUDAMED
Class II FDA UDI
Regulation Number
892.1570 FDA UDI
Market of Registration
Italy EUDAMED
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, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Rolled by Sheathing Technologies, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED…

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

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Manufacturer

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

Sources (3)

  • EUDAMED 58823077-9aea-45d5-b531-8055bf7447c6 61 fields · synced Oct 6, 2026
  • EUDAMED 74a405f9-54df-418e-9733-d4544526c55f 61 fields · synced May 19, 2026
  • FDA UDI 38b92f04-6a66-4a17-95bc-c2ff86dfa9a0 34 fields · synced May 30, 2026