AccessGUDID - DEVICE: Senhance (00815440020200)

GUDID

Device Identifier (DI) Information

Brand Name: Senhance
Version or Model: X0007032
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 210-11026
Company Name: Asensus Surgical, Inc.

Primary DI Number: 00815440020200
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 969118900 *Terms of Use

Device Description: Monopolar Maryland Dissector

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?
63111	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.	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 [?]
K171120	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
Length: 310 Millimeter
Outer Diameter: 5 Millimeter

Device Record Status

Public Device Record Key: 96034e0a-dfa0-41c9-8f6d-65398812a54c
Public Version Date: July 11, 2022
Public Version Number: 4
DI Record Publish Date: November 27, 2017

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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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