AccessGUDID - DEVICE: AxoTrack I Sterile Procedure Kit (30841517100156)

GUDID

Device Identifier (DI) Information

Brand Name: AxoTrack I Sterile Procedure Kit
Version or Model: P20810-03
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P20810
Company Name: FUJIFILM SONOSITE, INC.

Primary DI Number: 30841517100156
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 014438860 *Terms of Use

Device Description: Diagnostic Ultrasound System Accessory. Sterile needle guidance kit to be used with P11x ultrasound transducer.

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:	Yes
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?
60443	Ultrasound/electromagnetic-guided needle kit	A collection of sterile devices intended to be used during a needle entry procedure (e.g., central venous access, aspiration of pneumothorax) that combines ultrasonic and electromagnetic methods for needle guidance (e.g., needle depth data using Hall effect sensors virtually overlaid on ultrasound imaging). It typically includes the needle/cannula with a magnetic attachment, coupling gel, and casing intended to provide a sterile shield for a separate, compatible ultrasound/electromagnetic transducer. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYO	System, imaging, pulsed echo, ultrasonic
ITX	Transducer, ultrasonic, diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K113680	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
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Temperature: between 10 and 40 Degrees Celsius
Special Storage Condition, Specify: Shelf Life = 36 months

Clinically Relevant Size

[?]

Size Type Text
Needle Gauge: 18 Gauge

Device Record Status

Public Device Record Key: ce6c7cb7-e4ed-4a0b-9976-f9fd3e140d51
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 05, 2016