FDA.reportPublic FDA data

Premier Needle Adapter

Primary DI
00348783011357
Brand
Premier Needle Adapter
Company
PREMIER DENTAL PRODUCTS COMPANY
Model
1032454
Device description
ADAPTER NEEDLE 4 IN
Published
2026-06-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
GDMNeedle, Aspiration And Injection, Reusable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDMNeedle, Aspiration And Injection, ReusableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00348783011357PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00348783011357003487830113573487830113570348783011357

GMDN Terms#

Term, Definition table
TermDefinition
Luer needle extenderA slim, rigid tube intended to connect to a Luer needle to extend the length of the needle for access to anatomical sites that a standard length needle might not reach. It has a Luer connection at each end and does not incorporate any additional functionality. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
014789663
Device count
1
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00348783008265Premier Cavity Prep10031892026-04-01
00348783008722Premier Applicators10031152026-04-01
00348783008975Premier Pluggers10038162026-04-29
00348783008982Premier Pluggers10038172026-04-29
00348783009125Premier Pluggers10038022026-04-29
00348783009507Premier Spreader10039052026-05-06
00348783009514Premier Spreader10039062026-05-06
00348783010176Premier Crown Removers10035762026-04-02
00348783009064Premier Pluggers10038812026-03-17
00348783009361Premier Burnisher10030272026-03-17
D6919053036Premier REAMERS90530362023-10-17
00348783011234Premier Jarcho Cannula10308402026-06-10
00348783011340Premier Needle Adapter10324532026-06-10
00348783011364Premier Needle Adapter10324552026-06-10
00348783011371Premier Needle Adapter10324562026-06-10
00348783011456Premier Sawyer Retractor10501052026-06-10
00348783011463Premier Sawyer Retractor10501062026-06-10
00348783012415Premier Jackson Improved Short Tracheostomy Tube81000412026-06-10
00348783015591Bond-PR30052502026-06-10
00348783015607Bond-PR30052552026-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D9281071450ASPIRATING SYRINGE C-W TYPEW.H. Holden, Inc.GDM2026-10-12
00810130456802Medco ManufacturingMedco Manufacturing LLCGDM2026-08-25
00810130456772Medco ManufacturingMedco Manufacturing LLCGDM2026-08-07
14026704760555PILLINGTELEFLEX INCORPORATEDGDM2026-07-31
00810130456543Medco ManufacturingMedco Manufacturing LLCGDM2026-06-26
00348783011340Premier Needle AdapterPREMIER DENTAL PRODUCTS COMPANYGDM2026-06-10
00348783011364Premier Needle AdapterPREMIER DENTAL PRODUCTS COMPANYGDM2026-06-10
00348783011371Premier Needle AdapterPREMIER DENTAL PRODUCTS COMPANYGDM2026-06-10
00810130456499Medco ManufacturingMedco Manufacturing LLCGDM2026-06-05
00840516145884Anodyne SurgicalPsi/Eye-Ko, Inc.GDM2026-06-02
00810130456376Medco ManufacturingMedco Manufacturing LLCGDM2026-05-29
00810130456383Medco ManufacturingMedco Manufacturing LLCGDM2026-05-29
00810130456307Medco ManufacturingMedco Manufacturing LLCGDM2026-05-07
00810130456345Medco ManufacturingMedco Manufacturing LLCGDM2026-05-07
00810130456260Medco ManufacturingMedco Manufacturing LLCGDM2026-04-16
00810130456277Medco ManufacturingMedco Manufacturing LLCGDM2026-04-16
00810130456284Medco ManufacturingMedco Manufacturing LLCGDM2026-04-16
00810130455645Medco ManufacturingMedco Manufacturing LLCGDM2026-03-31
00810130455744Medco ManufacturingMedco Manufacturing LLCGDM2026-03-31
00810130455799Medco ManufacturingMedco Manufacturing LLCGDM2026-03-31
00810130455805Medco ManufacturingMedco Manufacturing LLCGDM2026-03-31
00810130455874Medco ManufacturingMedco Manufacturing LLCGDM2026-03-31
00810130455881Medco ManufacturingMedco Manufacturing LLCGDM2026-03-31
00810130455898Medco ManufacturingMedco Manufacturing LLCGDM2026-03-31
00810130455942Medco ManufacturingMedco Manufacturing LLCGDM2026-03-31
00810130455959Medco ManufacturingMedco Manufacturing LLCGDM2026-03-31
00810130455966Medco ManufacturingMedco Manufacturing LLCGDM2026-03-31
00810130456048Medco ManufacturingMedco Manufacturing LLCGDM2026-03-31
00810130456055Medco ManufacturingMedco Manufacturing LLCGDM2026-03-31
00810130456079Medco ManufacturingMedco Manufacturing LLCGDM2026-03-31