AccessGUDID - DEVICE: MR-SPOT (00815137021473)

GUDID

Device Identifier (DI) Information

Brand Name: MR-SPOT
Version or Model: 184S
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Beekley Corporation

Primary DI Number: 00815137021473
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 001157841 *Terms of Use

Device Description: MRI Skin Markers for Thoracic Spines, Larger Areas of Interest, 5.0cm Radiance filled packet

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
66941	Radiological image marker, noninvasive, single-use	A non-powered, noninvasive device intended to be placed within the field of view of a radiological device [diagnostic (e.g., x-ray) and/or radiation therapy] to produce an identifying mark [typically for an anatomical location (e.g., mole, nipple, lesion), orientation (e.g., right or left limb), or patient identification] on films or digital images; it is not intended to be used during surgery. It is typically in the form of a small sticker or clip, and is positioned on or next to the patient, or on the film cassette or holder; it is not intended to be placed on teeth. It is made from materials compatible with the imaging system. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JAC	System, X-Ray, Film Marking, Radiographic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c58ce840-5125-4fe2-89ce-a29dfcc228db
Public Version Date: September 16, 2024
Public Version Number: 2
DI Record Publish Date: July 22, 2019