AccessGUDID - DEVICE: ManuMix (04260056881565)

GUDID

Device Identifier (DI) Information

Brand Name: ManuMix
Version or Model: 02-0601
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 02-0602
Company Name: OSARTIS GmbH

Primary DI Number: 04260056881565
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 344261631 *Terms of Use

Device Description: ManuMix® is a mixing system for bone cements of low to medium viscosity and subsequent transfer in syringes for clinical application.

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:	Yes
Prescription Use (Rx):	No
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?
61468	Manual orthopaedic cement mixer, single-use	A sterile hand-operated device designed to mix polymethylmethacrylate (PMMA) powder with methylmethacrylate monomer in order to produce polymerizing bone cement. It typically consists of a vessel with attached/attachable mixing blades where the cement is mixed. It may include a plunger unit used to transfer the mixed cement from the vessel into an applicator prior to the surgical procedure, and a suction tube to enable connection to a separate fume extraction device. It is typically operated outside of the sterile surgical field and is not intended to contact the patient. 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
No Device Sizes

Device Record Status

Public Device Record Key: dfad0214-b60b-48f6-b9d4-481fda4602bf
Public Version Date: October 20, 2021
Public Version Number: 1
DI Record Publish Date: October 12, 2021