DEVICE: Single-Site; daVinci Si (00886874112090)

Device Identifier (DI) Information

Single-Site; daVinci Si
428090
In Commercial Distribution

INTUITIVE SURGICAL, INC.
00886874112090
GS1

1
938647021 *Terms of Use
PERMANENT CAUTERY HOOK
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Robotic electrosurgical instrument, monopolar, reusable An electrosurgical device intended to be connected directly to the arm of a robotic surgical system to deliver electrosurgical current in a monopolar configuration (i.e., in conjunction with a separate return electrode) from a generator directly to tissues for cutting/coagulation/ablation during robotic endoscopic (e.g., laparoscopic, arthroscopic) surgery. It includes a long thin body with a proximal housing intended to attach to the robotic arm, and may include the distal monopolar electrode in one of a variety of forms (e.g., forceps, hook). This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
NAY System,surgical,computer controlled instrument
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K130726 000
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Outer Diameter: 5 Millimeter
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Device Record Status

438c0abf-5b65-407a-962d-04469d60416b
September 13, 2018
7
July 08, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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