AccessGUDID - DEVICE: TRUMPF MEDICAL (00887761993204)

GUDID

Device Identifier (DI) Information

Brand Name: TRUMPF MEDICAL
Version or Model: 2064888
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Baxter Medical Systems GmbH + Co. KG

Primary DI Number: 00887761993204
Issuing Agency: GS1
Commercial Distribution End Date: March 01, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 330961223 *Terms of Use

Device Description: OR table top MR Neuro U

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
33152	Universal operating table, electromechanical	A mobile, electrically-powered motorized table designed to be adjusted to support a patient during many types of surgical interventions. The table surface may consist of many articulated sections that can be elevated or lowered for contouring to accommodate numerous anatomical positions (e.g., the whole table top may be adjusted to form a curved surface), or designed to be used in conjunction with dedicated accessories (i.e., positioners, traction devices) to satisfy the requirements of many clinical specialties; it may have x-ray transparent features.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDC	TABLE, OPERATING-ROOM, ELECTRICAL
JEA	TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED
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: da1c68d2-12d2-4b85-9191-a68cb43fefb2
Public Version Date: August 30, 2024
Public Version Number: 5
DI Record Publish Date: April 23, 2021