AccessGUDID - DEVICE: Piccolo Composite Plate System (07290109338613)

GUDID

Device Identifier (DI) Information

Brand Name: Piccolo Composite Plate System
Version or Model: Drill Bit
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PL930115
Company Name: CARBOFIX ORTHOPEDICS LTD

Primary DI Number: 07290109338613
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 649185170 *Terms of Use

Device Description: K-Wire for use with the Piccolo Composite Distal Radius and Proximal Humerus Plate Systems

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?
43390	Fluted surgical drill bit, single-use	A shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HRS	Plate, Fixation, Bone
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K102597	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 3.0 Millimeter
Length: 115 Millimeter

Device Record Status

Public Device Record Key: e969536e-a837-4c68-9f0a-c1459c38e226
Public Version Date: July 23, 2020
Public Version Number: 5
DI Record Publish Date: September 18, 2016