AccessGUDID - DEVICE: .018"(0.46MM) X 35CM ALLEVIO GUIDEWIRE (00810988020811)

GUDID

Device Identifier (DI) Information

Brand Name: .018"(0.46MM) X 35CM ALLEVIO GUIDEWIRE
Version or Model: JT110183500
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: JT110183500
Company Name: JET MEDICAL, INC.

Primary DI Number: 00810988020811
Issuing Agency: GS1
Commercial Distribution End Date: April 22, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 079506014 *Terms of Use

Device Description: .018" (0.46MM) X 35CM ALLEVIO GUIDEWIRE

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:	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?
16432	Nasopharyngeal catheter	A flexible tube intended to be used to access the nasopharyngeal cavity for suction or delivery of medication. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KCJ	Applicator, Ent

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: 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
Length: 35 Centimeter
Outer Diameter: .46 Millimeter
Outer Diameter: .018 Inch

Device Record Status

Public Device Record Key: 5ca835af-91c1-4684-aa37-f1e9cfb9eb0f
Public Version Date: May 03, 2019
Public Version Number: 4
DI Record Publish Date: July 20, 2015