AccessGUDID - DEVICE: EASYMIX® Nozzle slim (04260056880612)

GUDID

Device Identifier (DI) Information

Brand Name: EASYMIX® Nozzle slim
Version or Model: 02-0104
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 02-0104
Company Name: OSARTIS GmbH

Primary DI Number: 04260056880612
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 344261631 *Terms of Use

Device Description: The vacuum mixing systems EASYMIX® is a mixing systems for PMMA bone cements, which are indicated to be used with a mixing system. The mixing system is composed of the mixing cartridge with the socket, the mixing paddle with the handle, the funnel, the femoral pressurizer, the tubing to the vacuum pump and the standard nozzle. The EASYMIX® Nozzle slim is shorter and of smaller diameter than the standard nozzle provided with the EASYMIX® vacuum mixing system.

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?
45253	Orthopaedic cement preparation/delivery kit	A collection of sterile surgical instruments, tools, and materials designed to prepare and apply bone cement during an orthopaedic surgical procedure (e.g., hip replacement, arthroplasty, or vertebroplasty). It typically includes items such as forceps, a mallet, cement delivery injectors, delivery tubes, and mixing devices; it may or may not include bone cement. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JDZ	Mixer, Cement, For Clinical Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Outer Diameter: 8 Millimeter
Length: 173 Millimeter

Device Record Status

Public Device Record Key: 3feaf6c8-2580-426b-b81c-ba58995cb698
Public Version Date: December 09, 2022
Public Version Number: 1
DI Record Publish Date: December 01, 2022