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Xact

FDA UDI

Class I (US FDA UDI)

by Solstice Corp.

Identity

Trade Name
Xact FDA UDI
Generic Name
Radiographic image marker, manual FDA UDI
Device Name
Mammography area of concern marker, 10mm square, 80/box https://xactmarkers.com/product/tomosynthesis-area-of-concern-markers/ FDA UDI
Model / Reference
M10AC FDA UDI
Description
Mammography area of concern marker, 10mm square, 80/box https://xactmarkers.com/product/tomosynthesis-area-of-concern-markers/ FDA UDI

Identifiers

Catalog Number
M10AC FDA UDI
Primary DI / UDI-DI
00854623006143 FDA UDI
FDA Product Code
JAC FDA UDI
GMDN Term
Radiographic image marker, manual FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
892.1640 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Radiographic image marker, manualImaging lesion localization marker, external, single-use

Xact by Solstice Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Imaging lesion localization marker, external, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Solstice Corp.

Sources (1)

  • FDA UDI 2f6d5753-8e3f-4887-9d2c-d511bb58cb80 36 fields · synced May 30, 2026