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Scrip Hessco

FDA UDI

Class II (US FDA UDI)

by Scriphessco

Identity

Trade Name
Scrip Hessco FDA UDI
Generic Name
Ultrasound contrast medium, transuterine administration FDA UDI
Device Name
Scrip Hessco Ultrasound Gel Gallon FDA UDI
Model / Reference
663 0061 FDA UDI
Description
Scrip Hessco Ultrasound Gel Gallon FDA UDI

Identifiers

Primary DI / UDI-DI
00812433020001 FDA UDI
510(k) Number
K955246 FDA UDI
FDA Product Code
MUI FDA UDI
GMDN Term
Ultrasound contrast medium, transuterine administration 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

Category: Ultrasound contrast medium, transuterine administration

Scrip Hessco by Scriphessco — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K955246 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Scriphessco

Sources (1)

  • FDA UDI 9229f3de-8582-40d4-b94d-8fedc52f08c1 36 fields · synced Jun 6, 2026