AccessGUDID - DEVICE: Senhance Ultrasonic (00815440021573)

GUDID

Device Identifier (DI) Information

Brand Name: Senhance Ultrasonic
Version or Model: X9007620
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 300-11011
Company Name: Asensus Surgical, Inc.

Primary DI Number: 00815440021573
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 969118900 *Terms of Use

Device Description: Senhance Ultrasonic Transducer

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?
61828	Soft-tissue ultrasonic surgical system transducer/tip	A non-sterile component of an ultrasonic surgical system intended to convert high frequency electrical current from a generator into an ultrasonic oscillation at its distal tip to mechanically fragment soft-tissue cells upon contact for cutting and/or coagulating tissue during surgery. The tip makes direct (vibrating) patient contact and the device is typically used with a holder for the operator (not included). This is a non-dedicated device intended to be used in multiple clinical specialties. This is a reusable device intended to be sterilized prior to use.	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 [?]
K182421	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
No Device Sizes

Device Record Status

Public Device Record Key: 4bfd182c-1b7e-4c7f-9bd6-5374d141ac5f
Public Version Date: July 11, 2022
Public Version Number: 2
DI Record Publish Date: February 04, 2019

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: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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