AccessGUDID - DEVICE: neXus (00841626103023)

GUDID

Device Identifier (DI) Information

Brand Name: neXus
Version or Model: 110-31-2110
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MISONIX, INC.

Primary DI Number: 00841626103023
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 065963449 *Terms of Use

Device Description: neXus BoneScalpel® 10mm MIS, Blunt Blade, Sheath & Tubeset

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:	Yes
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?
60718	Hard-tissue ultrasonic surgical system handpiece tip	A sterile removable endpiece intended to be attached to an ultrasonic surgical system handpiece to amplify and deliver ultrasonic energy to mechanically fragment and cut bone upon contact during an orthopaedic surgical procedure (e.g., spinal surgery); some types may in addition be intended for dental/craniomaxillofacial applications (e.g., reconstructive/plastic surgery) however none are dedicated exclusively to dental applications. It is available in a variety of sizes and forms (e.g., blade, rasp), and is not intended to be held directly; a channel for surgical waste aspiration and a covering sleeve for delivery of irrigation solution may be included. This is a single-use device.	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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: aae11f6b-b7b0-46b4-858e-55039d77c542
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
00841626103320	5	00841626103023		In Commercial Distribution	box

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

Customer Contact

[?]

No Customer Contact currently defined

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