AccessGUDID - DEVICE: Simplex HV (04260056885747)

GUDID

Device Identifier (DI) Information

Brand Name: Simplex HV
Version or Model: 6194-1-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6194-1-010
Company Name: OSARTIS GmbH

Primary DI Number: 04260056885747
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 344261631 *Terms of Use

Device Description: Simplex® HV is a fast-setting acrylic resin for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone. Simplex® HV cement powder also contains insoluble zirconium dioxide as an X-ray contrast medium. Simplex® HV does not emit a signal and does not pose a safety risk in a magnetic resonance environment.

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):	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?
35217	Orthopaedic cement, non-antimicrobial	A substance designed to be used in arthroplastic and/or osteosynthetic procedures for the fixation of polymer or metallic implants to the living bone. It may also be intended for use as a filler in the case of bone pathologies (e.g., to stabilize and reinforce vertebral body structures in vertebroplasty and kyphoplasty). It is typically made from methylmethacrylate, polymethylmethacrylate (PMMA), esters of methacrylic acid or copolymers containing polymethylmethacrylate and polystyrene. This device does not contain an antimicrobial agent. After application, this device cannot be reused.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LOD	Bone Cement

FDA Premarket Submission

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

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
Handling Environment Temperature: between 17 and 25 Degrees Celsius
Special Storage Condition, Specify: Store between 0°C (32°F) and 25°C (77°C)

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 20 Milliliter
Weight: 40 Gram

Device Record Status

Public Device Record Key: 82d76c91-a204-41e8-97f1-9bc660fd4ac2
Public Version Date: June 19, 2020
Public Version Number: 4
DI Record Publish Date: September 24, 2015