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Marketlab, Inc

FDA UDI

Class II (US FDA UDI)

by Marketlab Inc.

Identity

Trade Name
Marketlab, Inc FDA UDI
Generic Name
Body-surface ultrasound imaging transducer cover FDA UDI
Device Name
Sterile Probe Cover, Gel and Bands, 5" x 48" with 3D End FDA UDI
Model / Reference
108239 FDA UDI
Description
Sterile Probe Cover, Gel and Bands, 5" x 48" with 3D End FDA UDI

Identifiers

Primary DI / UDI-DI
00817517026795 FDA UDI
FDA Product Code
ITX FDA UDI
GMDN Term
Body-surface ultrasound imaging transducer cover FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1570 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Body-surface ultrasound imaging transducer cover

Marketlab, Inc by Marketlab Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Body-surface ultrasound imaging transducer cover.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Marketlab Inc.

Sources (1)

  • FDA UDI 84815c32-8a57-409a-a2d1-11e82491748e 33 fields · synced May 30, 2026