FDA.reportPublic FDA data

Premier Rongeur

Primary DI
00348783010541
Brand
Premier Rongeur
Company
PREMIER DENTAL PRODUCTS COMPANY
Model
9065071
Device description
RONGEUR 1A
Published
2024-04-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EGNScissors, Surgical Tissue, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGNScissors, Surgical Tissue, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00348783010541PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00348783010541003487830105413487830105410348783010541

GMDN Terms#

Term, Definition table
TermDefinition
Dental rongeurA strongly constructed dental instrument that is used in the removal of the sharp edges of the alveolar crest of the bone following tooth extraction. It has a forceps or pliers-like design terminating at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws that bite (cut) through the bone tissue. It is made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
014789663
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00348783011135Premier Decann Stopper10378162026-05-27
00348783011920Poli-Pro Disks20190992026-05-27
00348783011975Poli-Pro Disks20190752026-05-27
00348783011982Poli-Pro Disks20190762026-05-27
00348783011999Poli-Pro Disks20190772026-05-27
00348783012019Poli-Pro Disks20190792026-05-27
00348783011913Poli-Pro Disks20190702026-05-26
00348783011937Poli-Pro Disks20190712026-05-26
00348783011951Poli-Pro Disks20190732026-05-26
00348783006919Premier Scalers056332026-05-06
00348783006971Premier Scalers056922026-05-06
00348783006988Premier Scalers056942026-05-06
00348783006995Premier Scalers056952026-05-06
00348783007251Premier Scalers90614002026-05-06
00348783007268Premier Scalers90614012026-05-06
00348783007275Premier Scalers90614022026-05-06
00348783007299Premier Scalers90614202026-05-06
00348783007329Premier Scalers90614232026-05-06
00348783007374Premier Scalers10046862026-05-06
00348783007398Premier Scalers10046882026-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08961104625853MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625860MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625877MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625884MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625891MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
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08961104625914MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625921MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625938MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625945MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625952MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625969MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625976MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625983MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625990MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104626003MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104626010MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104626027MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104626034MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104626041MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104626058MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104626096MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104626102MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104626119MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104626126MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104626133MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104626140MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22