AccessGUDID - DEVICE: Coulmed (10810087352575)

GUDID

Device Identifier (DI) Information

Brand Name: Coulmed
Version or Model: AC03-P
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AC03-P
Company Name: Coulmed Products Group LLC

Primary DI Number: 10810087352575
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 047115479 *Terms of Use

Device Description: Replacement 2" Thick Radiolucent Pad for Free-Access Style Hand & Arm Surgery Table, Standard Foam with Black Conductive Covering.

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?
37047	Arm procedure positioner, reusable	A preformed device designed to support and stabilize a patient's arm in a desired position during a medical procedure [e.g., orthopaedic surgery, anaesthesia administration, blood donation, intravenous (IV) infusion, physical therapy massage]. Also known as an arm posturing device or armboard, it is typically constructed as an elongated, curved, cushioned surface, and is typically attached or fixed onto a side rail, operation/examination table, blood donor couch, or a chair, and has adjustable height, tilt, rotation, and lock positioning capabilities. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CCX	SUPPORT, PATIENT POSITION

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: bc150a42-50cb-4362-b7ba-9732686d5dec
Public Version Date: January 16, 2023
Public Version Number: 1
DI Record Publish Date: January 06, 2023