DEVICE: Single-Site (00886874113707)

Device Identifier (DI) Information

Single-Site
478080
In Commercial Distribution

INTUITIVE SURGICAL, INC.
00886874113707
GS1

1
938647021 *Terms of Use
BIPOLAR MARYLAND
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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, bipolar, single-use A sterile electrosurgical device intended to be connected directly to the arm of a robotic surgical system to deliver electrosurgical current in a bipolar configuration (i.e., without a 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 bipolar electrode in one of a variety of forms (e.g., forceps, hook). This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
NAY System,surgical,computer controlled instrument
GCJ Laparoscope, general & plastic surgery
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K152448 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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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

50061748-c4c5-43f0-ab7d-f71e334d0540
July 06, 2018
3
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
10886874113704 6 00886874113707 In Commercial Distribution BOX
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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)

[?]
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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