AccessGUDID - DEVICE: eTRAX™ Needle (00841436103251)

GUDID

Device Identifier (DI) Information

Brand Name: eTRAX™ Needle
Version or Model: 610-1411-01
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 610-1411-01
Company Name: CIVCO MEDICAL INSTRUMENTS CO., INC.

Primary DI Number: 00841436103251
Issuing Agency: GS1
Commercial Distribution End Date: July 21, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 134614411 *Terms of Use

Device Description: Sterile needle, 14GA x 11cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIVCO 14GA needle sensor

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?
16835	Soft-tissue biopsy procedure kit, non-medicated	A collection of sterile devices designed to perform a non-specific soft tissue biopsy. It includes the biopsy needle used for this procedure; it does not include a pharmaceutical. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYO	System, imaging, pulsed echo, ultrasonic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K092619	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep Away from Sunlight
Storage Environment Temperature: between 52 and 85 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Length: 11 Centimeter
Needle Gauge: 14 Gauge

Device Record Status

Public Device Record Key: 1afe5544-8c6c-4660-b9be-1d5f5f153f7d
Public Version Date: September 03, 2021
Public Version Number: 4
DI Record Publish Date: August 28, 2017