FDA.reportPublic FDA data

J. Morita Disposable Needle 27G-21mm

Primary DI
14560266547181
Brand
J. Morita Disposable Needle 27G-21mm
Company
J. MORITA U.S.A., INC
Model
2027GS
Device description
Dental Disposable Needle 27G-21mm
Published
2019-03-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZMNeedle, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZMNeedle, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14560266547181PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1456026654718114560266547181

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
021866033
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08053610773781EFFITECTECNOFAR SPADZM2026-07-30
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08053610773804EFFITECTECNOFAR SPADZM2026-07-30
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