AccessGUDID - DEVICE: Coulmed (10810087355583)

GUDID

Device Identifier (DI) Information

Brand Name: Coulmed
Version or Model: TSK10-3PR-WON
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TSK10-3PR-WON
Company Name: Coulmed Products Group LLC

Primary DI Number: 10810087355583
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 047115479 *Terms of Use

Device Description: Replacement Pads for SKYTRON 6700, 6701, 6702 Surgical Tables. 3 Piece Set; 3" thick, Tier II Pressure Relief Visco Foam with Black Skin-Soft Conductive Covering...*Without Body Section Notch/Cutout*

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:	Yes
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?
31684	Operating table patient pressure distribution pad, reusable	A cushion (e.g., gel-filled, foam) intended to be placed between an operating table mattress or a patient positioner (e.g., torso intraoperative positioner, perineal post) and the patient to distribute the patient's body weight over a large surface area, for the prevention of pressure sores and tissue necrosis on prominent parts of the patient's body when immobilized for extended periods during surgery. It is available in various dimensions and shapes to accommodate various body parts such as the buttocks, shoulders, heels, or the entire body (usually excluding the head). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LWG	SURGICAL TABLE CUSHION

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: 132676d5-a29b-4f6d-b737-26819d81a4d4
Public Version Date: January 16, 2023
Public Version Number: 1
DI Record Publish Date: January 06, 2023