AccessGUDID - DEVICE: Siemens Medical Solutions (01618125163969)

GUDID

Device Identifier (DI) Information

Brand Name: Siemens Medical Solutions
Version or Model: 26968
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: TIDI PRODUCTS, LLC

Primary DI Number: 01618125163969
Issuing Agency: GS1
Commercial Distribution End Date: September 22, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 063519193 *Terms of Use

Device Description: Siemens Medical Solutions C-arm Equipment Covers Clear Polyethylene Sterile Fits Siemens Siremobil and Orbic 20 per Case

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:	Yes
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?
61676	Urological fluid funnel, sterile	A sterile device designed to be attached to a urological operating table (e.g., to a hoop frame) to channel fluids associated with a urological examination or surgery (i.e., body and irrigation fluids) from the table to an appropriate container, surgical suction system, or floor drain. It is typically constructed of flexible plastic material in the shape of funnel; it may include a filter, to trap tissue debris (e.g., urinary stones), and tubing. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KKX	Drape, 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: Yes
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: 72470cea-3646-48cc-b569-c320c8861f07
Public Version Date: September 23, 2022
Public Version Number: 3
DI Record Publish Date: October 12, 2016