AccessGUDID - DEVICE: Patient Support & Fixation (00887761971899)

GUDID

Device Identifier (DI) Information

Brand Name: Patient Support & Fixation
Version or Model: 1255814
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Baxter Medical Systems GmbH + Co. KG

Primary DI Number: 00887761971899
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 330961223 *Terms of Use

Device Description: Widening segment seat section TITAN U

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?
15325	Patient positioning vacuum pad	A device designed to position and immobilize parts of the patient (e.g., head, extremities) typically during therapeutic interventions or patient transportation. The device immobilizes a body part by encompassing it and then applying a vacuum. The device is typically an airtight soft pillow case type of covering made of flexible materials, e.g., plastic or rubber. When sealed, this device retains the shape of the part that it encompasses until the vacuum is released.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JEA	TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED
GDC	TABLE, OPERATING-ROOM, ELECTRICAL
KXJ	Table, radiologic

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: 9d887985-93b0-4518-bd8d-a2f42d6aad4e
Public Version Date: February 09, 2023
Public Version Number: 2
DI Record Publish Date: December 17, 2022