AccessGUDID - DEVICE: RONDO' (08032909627387)

GUDID

Device Identifier (DI) Information

Brand Name: RONDO'
Version or Model: Titanium Kirschner wire ø1.4mm L150mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1714150
Company Name: CITIEFFE SRL

Primary DI Number: 08032909627387
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 431406875 *Terms of Use

Device Description: Kirschner wire with trocar tip ø1.4mm L150mm. Material: titanium alloy Ti6Al4V ELI (ASTM F136).

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?
35685	Orthopaedic bone wire	A wire intended for the fixation of bone fractures that may be implanted or used short-term (e.g., to hold a plate in the correct position during an intervention). It may be used: 1) as a cerclage wire to aid bone fixation; 2) in a loop or figure-of-eight configuration to reattach, e.g., the tip of the elbow (olecranon), tibial tubercle, or greater trochanter; 3) to augment bone screw/plate fixation; or 4) as a Kirschner wire or K-Wire to stiffen (arthrodese) a toe or finger. It is made of metal [e.g., stainless steel, cobalt-chrome (Co-Cr)], and may be malleable or rigid; some types include a nut designed to be attached to the wire to prevent wire migration. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HTY	Pin, Fixation, Smooth
HTN	Washer, Bolt Nut
HWC	Screw, Fixation, Bone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K113388	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
Special Storage Condition, Specify: Dry and clean environment and avoid damaging the packing. Room temperature.

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 1.4 Millimeter
Length: 150 Millimeter

Device Record Status

Public Device Record Key: 497084d2-d7c8-46af-a556-e3f611ff6d63
Public Version Date: February 19, 2024
Public Version Number: 4
DI Record Publish Date: October 21, 2015