AccessGUDID - DEVICE: EndoWrist SP (00886874123478)

GUDID

Device Identifier (DI) Information

Brand Name: EndoWrist SP
Version or Model: 430200
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: INTUITIVE SURGICAL, INC.

Primary DI Number: 00886874123478
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 938647021 *Terms of Use

Device Description: NEEDLE DRIVER

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?
64421	Robotic surgical needle holder, reusable	A surgical device intended to be used in conjunction with a robotic surgical system, to grasp a suture needle when pushing/pulling the needle and attached suture through tissue for suturing during a robotic endoscopic (e.g., laparoscopic) procedure. It has a long slender shaft with a distal forceps-like gripping mechanism and a proximal housing intended to be connected directly to an arm of the robotic surgical system. 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 [?]
K241814	000

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: 6 Millimeter

Device Record Status

Public Device Record Key: b9d51468-66ba-4772-ac8a-a9a6c4fc14f9
Public Version Date: December 17, 2024
Public Version Number: 1
DI Record Publish Date: December 09, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

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: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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