AccessGUDID - DEVICE: NeuroTrace (B33955718090)

GUDID

Device Identifier (DI) Information

Brand Name: NeuroTrace
Version or Model: 557-18-09
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 557-18-09
Company Name: NEO MEDICAL INC.

Primary DI Number: B33955718090
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, 18ga x 3.5" (89 mm), Tuohy 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?
46383	Peripheral anaesthesia catheter set, non-medicated	A collection of devices intended for the continuous-administration of an anaesthetic agent (not included) to function as a peripheral nerve-block. It includes an anaesthesia needle and an anaesthesia catheter usually with additional devices utilized for the procedure (e.g., connectors, catheter holder). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAZ	Anesthesia Conduction Kit

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K994059	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: 89 Millimeter
Length: 3.5 Inch
Needle Gauge: 18 Gauge

Device Record Status

Public Device Record Key: e9fc37bd-da3d-4826-bb40-f70292e5c6db
Public Version Date: July 22, 2019
Public Version Number: 4
DI Record Publish Date: September 24, 2016