AccessGUDID - DEVICE: KALIX® (10381780051572)

GUDID

Device Identifier (DI) Information

Brand Name: KALIX®
Version or Model: 119867ND
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: NEWDEAL

Primary DI Number: 10381780051572
Issuing Agency: GS1
Commercial Distribution End Date: May 28, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 536935331 *Terms of Use

Device Description: The size 17 stainles steel trial implant is used by the surgeon to choose the size of the final implant in the treatment of the hyperpronated foot and the stabilization of the subtalar joint.

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:	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?
46479	Surgical implant template, reusable	A device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HWT	TEMPLATE

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 18mm diameter X 18.5mm length

Device Record Status

Public Device Record Key: 82f8014d-e6f7-45a4-9f15-0dfd15460d57
Public Version Date: January 26, 2023
Public Version Number: 4
DI Record Publish Date: May 26, 2017