AccessGUDID - DEVICE: Monarch™ Individual Hand Grips (00841439112595)

GUDID

Device Identifier (DI) Information

Brand Name: Monarch™ Individual Hand Grips
Version or Model: OAP160
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: OAP160
Company Name: MEDTEC, INC.

Primary DI Number: 00841439112595
Issuing Agency: GS1
Commercial Distribution End Date: August 04, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 103977526 *Terms of Use

Device Description: For use with C-Qual™

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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:	No
Prescription Use (Rx):	Yes
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?
40899	Radiological breast positioner, non-wearable	A device that is specifically designed to ensure adequate positioning and immobilization of the female patient's breast(s) and chest during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures. The device is in the form of a frame, board, cushion, or preformed pad (non-wearable device) and may also be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYE	Accelerator, linear, medical
LNH	System, nuclear magnetic resonance imaging

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K093738	000
K974703	000

Device Exempt from Premarket Submission: No 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: 2885c59e-c87b-4847-8fbb-54a686f2fd7d
Public Version Date: August 04, 2023
Public Version Number: 5
DI Record Publish Date: January 07, 2019