FDA.reportPublic FDA data

Premier Needle Adapter

Primary DI
00348783011340
Brand
Premier Needle Adapter
Company
PREMIER DENTAL PRODUCTS COMPANY
Model
1032453
Device description
ADAPTER NEEDLE 3 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
00348783011340PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00348783011340003487830113403487830113400348783011340

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
00348783011234Premier Jarcho Cannula10308402026-06-10
00348783011357Premier Needle Adapter10324542026-06-10
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
00348783015614Bond-PR30052692026-06-10
00348783010640Premier Jackson Original Tracheostomy Tube10343002026-06-09
00348783010657Premier Jackson Original Tracheostomy Tube10343102026-06-09
00348783010664Premier Jackson Original Tracheostomy Tube10343112026-06-09
00348783010671Premier Jackson Original Tracheostomy Tube10343122026-06-09
00348783010695Premier Jackson Original Tracheostomy Tube10343142026-06-09
00348783010701Premier Jackson Original Tracheostomy Tube10343152026-06-09
00348783010718Premier Jackson Original Tracheostomy Tube10343162026-06-09
00348783010725Premier Jackson Original Tracheostomy Tube10343172026-06-09
00348783010732Premier Jackson Original Tracheostomy Tube10343182026-06-09
00348783010749Premier Jackson Original Tracheostomy Tube10343192026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810130456543Medco ManufacturingMedco Manufacturing LLCGDM2026-06-26
00348783011357Premier 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
00810130456147Medco ManufacturingMedco Manufacturing LLCGDM2026-03-31
00810130456154Medco ManufacturingMedco Manufacturing LLCGDM2026-03-31
14026704934598PILLINGTELEFLEX INCORPORATEDGDM2026-03-06
14026704934604PILLINGTELEFLEX INCORPORATEDGDM2026-03-06