AccessGUDID - DEVICE: CosmoLock Pedicle Screw System (B07310K0191120)

GUDID

Device Identifier (DI) Information

Brand Name: CosmoLock Pedicle Screw System
Version or Model: 10-K01-9112
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Kalitec Direct LLC

Primary DI Number: B07310K0191120
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 041956211 *Terms of Use

Device Description: Dilator, Medium

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):	No
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?
32338	Fascial tissue dilator, reusable	A surgical instrument used for stretching or enlarging the fascial tissue covering a cavity, tract, or opening typically prior to the introduction of a catheter during an invasive diagnostic or surgical procedure (e.g., femoral artery catheterization). It is a rod-like device with a long, slender, hollow or solid body and a rounded nose at its distal end, that is available in a variety of sizes and made of metal (e.g., stainless steel). It is typically used for the dilatation of fascial tissue around peripheral vasculature, puncture sites, and various ducts. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEA	Cannula, Surgical, General & Plastic Surgery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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
No Device Sizes

Device Record Status

Public Device Record Key: d3c3d2f9-1238-4a46-b060-ef30d947aefc
Public Version Date: October 15, 2018
Public Version Number: 1
DI Record Publish Date: September 14, 2018