Device
ALIGNMENT RING ASSEMBLY, SSF
Manufacturer
IMRIS Imaging, Inc.
Model: P122506 DI: 00850085914002 Status: New MRI: MR Conditional Single-use: No Rx: Yes OTC: No
First Published: 2026-05-07 Current Version: 2026-05-15
Description
ALIGNMENT RING ASSEMBLY, SSF
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: a725c12d-c8ee-4524-9652-eb256fc92209
Distribution Status: In Commercial Distribution
DUNS Number: 079990922
Device Count: 1
DM Exempt: No
Premarket Exempt: Yes
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: No
Serial Number Tracked: Yes
Manufacturing Date Tracked: Yes
Expiration Date Tracked: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 00850085914002
Type: Primary
Issuing Agency: GS1
GMDN
Code: 61131
Name: Radiological general body-part positioner
Definition:
A device intended to facilitate adequate positioning and immobilization of a patient’s body part during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures; it is not dedicated to a specific part of the body. The device is in the form of a frame, board, cushion, or preformed pad that may also be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.
FDA Product Codes
FTY
Tape, Measuring, Rulers And Calipers