FDA.report

MediDent

Primary DI
16971911290488
Brand
MediDent
Company
Jiangsu Micsafe Medical Tehcnology Co.,LTD.
Model
1
Device description
1ml luer lock syringe without needle
Published
2021-01-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
FMFSyringe, Piston

Product Code Classifications

CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
16971911290488PackageGS1100In Commercial Distribution
26971911290485PackageGS13600In Commercial Distribution
06971911290481PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1697191129048816971911290488
2697191129048526971911290485
06971911290481069719112904816971911290481

GMDN Terms

TermDefinition
General-purpose syringe, single-useA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
554400604
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
16971911290723micsafe 12023-05-31
16971911290730micsafe 12023-05-31
16971911290747micsafe 12023-05-31
16971911290754micsafe 12023-05-31
16971911290761micsafe 12023-05-31
16971911290778micsafe 12023-05-31
16971911291072micsafe 12023-05-31
16971911291089micsafe 12023-05-31
06971911291099BIAL12023-05-31
06971911291105BIAL12023-05-31
06971911291112BIAL12023-05-31
06971911291129BIAL12023-05-31
06971911291143BIAL12023-05-31
06971911291150BIAL12023-05-31
06971911291167BIAL12023-05-31
16971911291171micsafe 12023-05-31
16971911291188micsafe 12023-05-31
16971911291195micsafe 12023-05-31
16971911291508micsafe 12023-05-31
16971911291515micsafe 12023-05-31

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