AccessGUDID - DEVICE: MicronJet 600 (17290015928011)

GUDID

Device Identifier (DI) Information

Brand Name: MicronJet 600
Version or Model: AS4008
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: NANOPASS TECHNOLOGIES LTD

Primary DI Number: 17290015928011
Issuing Agency: GS1
Commercial Distribution End Date: July 14, 2019
Device Count: 100
Labeler D-U-N-S® Number*: 532670536 *Terms of Use

Device Description: a female luer connector equipped with a chip having three microneedles; each microneedle is 0.6 mm (600 micron) in length (height). This device can be mounted on any standard syringe (Luer Slip or Luer Lock connection)

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?
59230	Hypodermic needle, single-use	A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMI	Needle, Hypodermic, Single Lumen

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K092746	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
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 600 Micrometer

Device Record Status

Public Device Record Key: 0e471c43-8699-4c95-8b9f-8b145ace1f1d
Public Version Date: October 23, 2019
Public Version Number: 7
DI Record Publish Date: June 01, 2016