FDA.reportPublic FDA data

EFFITEC

Primary DI
08053610773804
Brand
EFFITEC
Company
TECNOFAR SPA
Model
27G SHORT
Catalog number
C3210_US
Device description
1 box of 100 single use needles 27G 16mm
Published
2026-07-30
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

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
08053610773804PrimaryGS10
08053610773774Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08053610773804080536107738048053610773804
08053610773774080536107737748053610773774

GMDN Terms#

Term, Definition table
TermDefinition
Dental syringe needle, single-useA sterile, sharp bevel-edged, hollow tubular metal instrument with an integral hub, typically intended to be attached to a dental cartridge syringe for the injection of local anaesthetics. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Regulatory Flags#

DUNS number
428682363
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08053610773781EFFITEC30G EXTRA SHORTC3200_US2026-07-30
08053610773798EFFITEC30G SHORTC3205_US2026-07-30
08053610772777SIRIOSIRIO 27Gx35 FA112024-05-27
08053610772784SIRIOSIRIO 27Gx38 FA112024-05-27
08053610772791SIRIOSIRIO 30Gx25 FA112024-05-27
08053610772814SIRIOSIRIO 27Gx38 FA112024-05-27
08053610772203SUPPRA JECT SUPPRA JECT 30Gx252023-10-17
08053610772210SUPPRA JECT SUPPRA JECT 30Gx102023-10-17
08053610772227SUPPRA JECT SUPPRA JECT 27Gx252023-10-17
08053610772234SUPPRA JECT SUPPRA JECT 27Gx352023-10-17
08053610771619FAIRFAX DENTALFairfax Dental 27Gx82023-07-24
08053610771626FAIRFAX DENTALFairfax Dental 27Gx322023-07-24
08053610771633FAIRFAX DENTALFairfax Dental 30Gx212023-07-24
08053610772098FAIRFAX DENTALFairfax Dental 27Gx82023-07-24
08053610772104FAIRFAX DENTALFairfax Dental 27Gx322023-07-24
08053610772111FAIRFAX DENTALFairfax Dental 30Gx212023-07-24
08053610771848ORABLOCOrabloc Needle thirthyS2023-06-22
08053610771855ORABLOCOrabloc Needle thirthyES2023-06-22
08053610771862ORABLOCOrabloc Needle twenty7S2023-06-22
08053610771879ORABLOCOrabloc Needle twenty7L2023-06-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08053610773781EFFITECTECNOFAR SPADZM2026-07-30
08053610773798EFFITECTECNOFAR SPADZM2026-07-30
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