AccessGUDID - DEVICE: EndoWrist;daVinci Si (00886874111109)

GUDID

Device Identifier (DI) Information

Brand Name: EndoWrist;daVinci Si
Version or Model: 410299
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: INTUITIVE SURGICAL, INC.

Primary DI Number: 00886874111109
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 938647021 *Terms of Use

Device Description: SUCTION/IRRIGATOR

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):	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?
64426	Robotic surgical irrigation/aspiration cannula, single-use	An atraumatic, invasive tube intended to be connected directly to the arm of a robotic surgical system and designed as a conduit to allow irrigation and aspiration (i.e., capable of both functions) of body cavities/wounds during a robotic surgical (e.g., laparoscopic) procedure, typically to facilitate observation; it may additionally be used for tissue manipulation. It is typically a long, slim, rigid tube with a proximal housing that connects to an arm of the robotic surgical system; it may include connection tubing and additional tubing set components (e.g., clamps, filters, connectors). It is not designed to administer parenteral fluids or drugs. This is a single-use 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: 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
Outer Diameter: 8 Millimeter

Device Record Status

Public Device Record Key: b4d037a7-fc9e-42e7-8483-e16163413ce4
Public Version Date: December 13, 2023
Public Version Number: 7
DI Record Publish Date: July 08, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10886874111106	6	00886874111109		In Commercial Distribution	BOX

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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