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Xact M15R

by Solstice Corp.

Xact M15R is a Class I device made by Solstice Corp., listed in FDA GUDID since 26 Feb 2021 (UDI-DI 00854623006136), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00854623006136 UDI-DI Date26 Feb 2021ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Xact
Generic name
Radiographic image marker, manual
Model / Ref / Catalog
M15R
Description
X-ray imaging marker for extremities, 15mm circle, 60/box https://xactmarkers.com/product/skeletal-ring-markers-m15r/
Primary DI / UDI-DI
00854623006136
FDA product code
JAC
GMDN term
Radiographic image marker, manual
Device class
Class I
Regulation number
892.1640
GUDID distribution status
In Commercial Distribution

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Properties

  • Single use
  • Premarket exempt
Other properties (13, all answered No)