AccessGUDID - DEVICE: Guidewire Introducer Needle (00813079020332)

GUDID

Device Identifier (DI) Information

Brand Name: Guidewire Introducer Needle
Version or Model: GWI-1902
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GWI-1902
Company Name: REMINGTON MEDICAL, INC.

Primary DI Number: 00813079020332
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 788472314 *Terms of Use

Device Description: 19ga (1.1mm) x 7 cm

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?
12747	Intra-arterial needle	A sterile, sharp bevel-edged, hollow tubular metal instrument designed to puncture an artery. The needle may be heparinized to prevent blood clotting. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DWS	INSTRUMENTS, SURGICAL, CARDIOVASCULAR

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: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Needle Gauge: 19 Gauge

Device Record Status

Public Device Record Key: bd83aa67-bacc-42f5-936a-d040a73320e0
Public Version Date: October 02, 2020
Public Version Number: 1
DI Record Publish Date: September 24, 2020