FDA.reportPublic FDA data

MicronJet

Primary DI
17290015928295
Brand
MicronJet
Company
NANOPASS TECHNOLOGIES LTD
Model
800X3
Catalog number
AS4059
Device description
A female luer connector equipped with a chip having 3 microneedles; each microneedle is 0.8 mm (800 micron) in length (height).This device can be mounted on any standard syringe (luer slip or luer lock connection)
Published
2023-01-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092746000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092746000MICRONJET 600Nanopass Technologies , Ltd.2010-02-03FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290015928295PrimaryGS10
07290015928298Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001592829517290015928295
07290015928298072900159282987290015928298

GMDN Terms#

Term, Definition table
TermDefinition
Hypodermic needle, single-useA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0.8Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-10 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
532670536
Device count
30
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17290015928257MicronJet600AS40552023-08-06
17290015928271MicronJet800X3AS40572023-02-15
17290015928226MicronJet 600S4013_12022-08-17
17290015928011MicronJet 600AS40082016-06-01
17290015928035MicronJet 600AS40132018-07-01
17290015928080MicronJet 600AS40182017-08-01

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Primary DI, Brand, Company table
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