AccessGUDID - DEVICE: Rex Mallet (D894040001310)

GUDID

Device Identifier (DI) Information

Brand Name: Rex Mallet
Version or Model: Rex Mallet
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 04000131
Company Name: Rex Implants, Inc.

Primary DI Number: D894040001310
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080746478 *Terms of Use

Device Description: Package includes Rex Mallet Console and the following individually packaged accessories: Rex Mallet Handpiece, Rex Mallet Foot Pedal, P. Striker / Remover, Wrench (not a medical device), and Rex Mallet Handpiece Holder (not a medical device)

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:	No
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?
32856	Orthopaedic implant impactor, reusable	A metal and/or plastic hand-held manual surgical instrument designed to position an orthopaedic implant within the body by transmission of an impact force that drives the implant into its final position. The proximal end of the instrument is a handle usually designed to absorb the impact from a surgical hammer or mallet, and the distal end is usually shaped to conform to the implant shape (flat or anatomically curved) or is shaped like a chisel handle to facilitate implant positioning. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEY	Motor, Surgical Instrument, Ac-Powered

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -10 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c31d31a9-1e37-4e80-a5dd-cec50bf38d9a
Public Version Date: August 08, 2024
Public Version Number: 4
DI Record Publish Date: January 07, 2023