AccessGUDID - DEVICE: Trumpf Medical (00887761995819)

GUDID

Device Identifier (DI) Information

Brand Name: Trumpf Medical
Version or Model: 4023312
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Baxter Medical Systems GmbH + Co. KG

Primary DI Number: 00887761995819
Issuing Agency: GS1
Commercial Distribution End Date: January 01, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 330961223 *Terms of Use

Device Description: Hospital Device

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?
44975	Medical equipment handle cover, reusable	A device designed specifically to cover the handle of a piece of medical equipment (e.g., operating light) to provide a physical sterile barrier between the handle and the hand of a healthcare professional, e.g., during a surgical procedure. It is typically a rigid polymer device designed for attachment to a handle and may in addition provide grip for improved manipulation of the handle; it is not designed to cover other equipment components. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FQP	Lamp, operating-room
FSQ	Light, surgical, instrument
FSY	Light, surgical, ceiling mounted
FTD	Lamp, surgical

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: f93f51fd-e548-422b-9fca-3f6aaad94dbf
Public Version Date: February 13, 2025
Public Version Number: 5
DI Record Publish Date: September 17, 2016