AccessGUDID - DEVICE: EndoWrist;daVinci Si (00886874111451)

GUDID

Device Identifier (DI) Information

Brand Name: EndoWrist;daVinci Si
Version or Model: 420170
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: INTUITIVE SURGICAL, INC.

Primary DI Number: 00886874111451
Issuing Agency: GS1
Commercial Distribution End Date: September 01, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 938647021 *Terms of Use

Device Description: ENDOPASS DELIVERY

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):	Yes
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?
58050	Ligation clip cartridge holder	A device designed to hold sterile ligation clip cartridges to facilitate quick reloading of the cartridges into a surgical clip applier during a surgical procedure. It is typically made of metal and plastic materials in the form of a flat and stable base with profiled slots in its upper surface into which many ligation clip cartridges are held ready for loading. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NAY	System,surgical,computer controlled instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 8 Millimeter

Device Record Status

Public Device Record Key: 2aca953b-25fd-41b9-b27b-ec9968a186db
Public Version Date: April 30, 2020
Public Version Number: 5
DI Record Publish Date: July 08, 2016