AccessGUDID - DEVICE: PALACOS® (04260102136182)

GUDID

Device Identifier (DI) Information

Brand Name: PALACOS®
Version or Model: R+G pro 40
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5081288
Company Name: Heraeus Medical GmbH

Primary DI Number: 04260102136182
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 333623937 *Terms of Use

Device Description: The PALACOS® R+G pro system consists of a mixing and application system prefilled with PALACOS® polymer powder and monomer liquid. PALACOS® R+G pro is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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:	Yes
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?
46059	Orthopaedic cement, antimicrobial	A substance designed to be used in arthroplastic and/or osteosynthetic procedures for the fixation of polymer or metallic prosthetic implants to the living bone and/or to fill voids in the case of bone pathologies, and to treat infected joint prostheses or osteomyelitis; it may also be used prophylactically in primary or uninfected revision total joint arthroplasty. It is typically made from methylmethacrylate, polymethylmethacrylate (PMMA), esters of methacrylic acid or copolymers containing polymethylmethacrylate and polystyrene, and contains an antimicrobial agent. After application, this device cannot be reused.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MBB	Bone Cement, Antibiotic
KIH	Dispenser, Cement
JDZ	Mixer, Cement, For Clinical Use
LOD	Bone Cement

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K210607	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
Storage Environment Temperature: between 4 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 28eb2ce9-39c2-4856-a864-7806a716d90f
Public Version Date: October 25, 2023
Public Version Number: 2
DI Record Publish Date: July 15, 2021