AccessGUDID - DEVICE: neXus (00841626102668)

GUDID

Device Identifier (DI) Information

Brand Name: neXus
Version or Model: 100-21-0003
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MISONIX, INC.

Primary DI Number: 00841626102668
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 065963449 *Terms of Use

Device Description: neXus SonicOne® O.R. Standard Front Housing

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":	Yes
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?
60719	Ultrasonic surgical system handpiece cooling sleeve	A removable attachment to an ultrasonic surgical system handpiece intended to contain the flow of coolant liquid, supplied through the handpiece, over the ultrasonic surgical system handpiece tip; the coolant is intended to prevent overheating of the tip during a surgical procedure. It is typically a funnel-shaped sleeve designed to fit over the distal end of the handpiece and cover a portion of the tip. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LFL	Instrument, Ultrasonic Surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K190160	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: bf58b7f8-1cc7-41c0-80f3-10ebbda4fe11
Public Version Date: March 03, 2020
Public Version Number: 1
DI Record Publish Date: February 24, 2020

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

Customer Contact

[?]

No Customer Contact currently defined

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