FDA.reportPublic FDA data

SIRIO

Primary DI
08053610772791
Brand
SIRIO
Company
TECNOFAR SPA
Model
SIRIO 30Gx25 FA11
Device description
Disposable Dental Needle 30Gx25
Published
2024-05-27
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

Contact Domains#

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
08053610772791PrimaryGS10
08053610771893Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08053610772791080536107727918053610772791
08053610771893080536107718938053610771893

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.

Contacts#

Phone, Email table
PhoneEmail
+39 0342684115quality@tecnofar.it

Regulatory Flags#

DUNS number
428682363
Device count
100
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08053610773781EFFITEC30G EXTRA SHORTC3200_US2026-07-30
08053610773798EFFITEC30G SHORTC3205_US2026-07-30
08053610773804EFFITEC27G SHORTC3210_US2026-07-30
08053610772777SIRIOSIRIO 27Gx35 FA112024-05-27
08053610772784SIRIOSIRIO 27Gx38 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
08053610773804EFFITECTECNOFAR SPADZM2026-07-30
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