AccessGUDID - DEVICE: Body Pro-Lok ONE™ System (00841439102336)

GUDID

Device Identifier (DI) Information

Brand Name: Body Pro-Lok ONE™ System
Version or Model: BPL100
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: BPL100
Company Name: MEDTEC, INC.

Primary DI Number: 00841439102336
Issuing Agency: GS1
Commercial Distribution End Date: March 20, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 103977526 *Terms of Use

Device Description: Reusable non-sterile ONEPlatform with lok-bar, ONEBridge, storage base, respiratory belt, repiratory plate, clam-lok cusion, kneefix cushion, and feetfix cushion

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?
40902	Radiological whole-body positioner	A device comprised of fixed or adjustable position elements designed to ensure adequate positioning and/or immobilization of a patient's whole body during diagnostic imaging, image guided surgical or interventional procedures, and/or radiation therapy procedures; it may in addition be used to position a patient’s body part (however it is not dedicated to a specific part of the body). It is in the form of a frame, board, cushion, or preformed pad and may 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 [?]
K111340	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
Width: 24.1 Inch
Length: 72 Inch

Device Record Status

Public Device Record Key: 2110069e-16a0-4f58-befe-dd429b683642
Public Version Date: May 23, 2019
Public Version Number: 6
DI Record Publish Date: August 02, 2017