AccessGUDID - DEVICE: NeuroTrace (B33955325040)

GUDID

Device Identifier (DI) Information

Brand Name: NeuroTrace
Version or Model: 553-25-04
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 553-25-04
Company Name: NEO MEDICAL INC.

Primary DI Number: B33955325040
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 015510540 *Terms of Use

Device Description: Insulated Electro-Needle for use in Regional Anesthesia, 25ga x 1.5" (38mm), B Bevel

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	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?
61546	Nerve-locating anaesthesia needle	A sterile device intended to functions as: 1) an electrode during nerve/nerve plexus location; and 2) as a conduit for administration of a local anaesthetic during peripheral nerve-blocking. It is a sharp, hollow, tubular, electrically-insulated metal needle with an uninsulated bevelled tip, intended to be used with an electrical pulse generator and an appropriate anaesthetic-filled syringe. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K032981	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
Special Storage Condition, Specify: Keep Away From Sunlight
Special Storage Condition, Specify: Keep Dry

Clinically Relevant Size

[?]

Size Type Text
Length: 38 Millimeter
Length: 1.5 Inch
Needle Gauge: 25 Gauge

Device Record Status

Public Device Record Key: 15a07661-0bba-4c75-9912-1782f1c6a00c
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016