AccessGUDID - DEVICE: TRENDELENBURG STABILIZER 6/PK (00733657249828)

GUDID

Device Identifier (DI) Information

Brand Name: TRENDELENBURG STABILIZER 6/PK
Version or Model: 937126
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2970014760
Company Name: ALIMED, INC.

Primary DI Number: 00733657249828
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 056007248 *Terms of Use

Device Description: No description.

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":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
65604	Operating table neck/shoulder positioner	A device designed to be attached to an operating table to support and immobilize the neck and shoulders of a patient for stabilization when placed in the Trendelenburg position during a surgical procedure. It typically incorporates cushions or pads that enable adjustable positioning along the operating table. 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: 444bb977-73ae-4d71-8b5a-8ba757dad371
Public Version Date: February 26, 2024
Public Version Number: 3
DI Record Publish Date: December 01, 2022