AccessGUDID - DEVICE: COMPRESSION PADDLE (00843696114312)

GUDID

Device Identifier (DI) Information

Brand Name: COMPRESSION PADDLE
Version or Model: 14107
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Flow X Ray Corporation

Primary DI Number: 00843696114312
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 010016319 *Terms of Use

Device Description: Designed for applying compression during G.I. series, our Wolf Compression Paddle is ideal for displacing barium, deflecting an intestinal loop, or applying compression for similar reasons. The Paddle features a rubber compression bladder, easily inflated by means of a built-in baumanometer bulb. A metal circle in the bladder ring fluoroscopically indicates the area under compression.

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):	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?
66669	Radiological inflatable compression paddle	A noninvasive manual device designed to provide external compression to specific areas of the abdomen/pelvis to move internal organs (e.g., large intestines, bladder, kidneys) during a diagnostic radiological procedure. It typically consists of a handle, with a hand pump, and a distal paddle with an inflatable ball. Typically, the paddle is placed under the patient and the ball inflated to provide compression to the selected anatomical region. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HWN	Instrument, Compression

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: cb9f594d-4711-4707-b943-80cf233c9e62
Public Version Date: February 27, 2024
Public Version Number: 3
DI Record Publish Date: December 22, 2022