AccessGUDID - DEVICE: HipFix® Baseplate (00841439107058)

GUDID

Device Identifier (DI) Information

Brand Name: HipFix® Baseplate
Version or Model: MTPLVC04
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: MTPLVC04
Company Name: MEDTEC, INC.

Primary DI Number: 00841439107058
Issuing Agency: GS1
Commercial Distribution End Date: October 11, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 103977526 *Terms of Use

Device Description: (79 x 60 x 1cm)

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:	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?
40901	Radiological pelvis positioner	A device intended to facilitate adequate positioning and immobilization of the patient's pelvic area 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 that 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
LNH	System, nuclear magnetic resonance imaging
IYE	Accelerator, linear, medical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K093738	000
K950866	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
Special Storage Condition, Specify: Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 798300f6-f433-4857-af05-4a2319e11eac
Public Version Date: October 11, 2021
Public Version Number: 8
DI Record Publish Date: August 02, 2017