FDA.reportPublic FDA data

Magic Needle

Primary DI
03760264550235
Brand
Magic Needle
Company
NEEDLE CONCEPT
Model
MN22G57/21G
Published
2019-04-05
Public version status
Update
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
K110606000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110606000MV INTRADERMIC NEEDLES; MAGIC NEEDLE; MAGIC NEEDLEM.V.S.R.L.2011-09-29FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760264550235PrimaryGS10
03760264550068Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760264550235037602645502353760264550235
03760264550068037602645500683760264550068

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
260304984
Device count
20
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760264550013Magic NeedleMN30G27/27G2019-04-05
03760264550174Magic NeedleMN27G37/26G2019-04-05
03760264550181Magic NeedleMN27G37/26G2019-04-05
03760264550198Magic NeedleMN25G50/23G2019-04-05
03760264550204Magic Needle MN25G40/23G2019-04-05
03760264550211Magic NeedleMN25G40/23G2019-04-05
03760264550228Magic NeedleMN22G70/21G2019-04-05

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