FDA.reportPublic FDA data

Brasseler USA

Primary DI
00887919414414
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5001931U0
Device description
53R FORCEP 1P
Published
2022-12-08
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
EMGFORCEPS, TOOTH EXTRACTOR, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMGForceps, Tooth Extractor, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887919414414PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919414414008879194144148879194144140887919414414

GMDN Terms#

Term, Definition table
TermDefinition
Tooth extraction forcepsA hand-held manual dental surgical instrument shaped like pincers and designed for the extraction of teeth. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
082080136
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887919581727DENTFLEX FIBER POST5013918L05013918L02026-09-25
00887919581741DENTFLEX FIBER POST5013919L05013919L02026-09-25
00887919581765DENTFLEX FIBER POST5013920L05013920L02026-09-25
08404535030334Brasseler USA5032038U05032038U02026-09-25
08404535030365Brasseler USA5032039U05032039U02026-09-25
08404535030396Brasseler USA5032040U05032040U02026-09-25
08404535030426Brasseler USA5032041U05032041U02026-09-25
08404535030433Brasseler USA5032042U05032042U02026-09-25
08404535030464Brasseler USA5032043U05032043U02026-09-25
08404535030488Brasseler USA5032044U05032044U02026-09-25
08404535030518Brasseler USA5032045U05032045U02026-09-25
08404535030549Brasseler USA5032046U05032046U02026-09-25
08404535030570Brasseler USA5032047U05032047U02026-09-25
08404535030600Brasseler USA5032048U05032048U02026-09-25
08404535030631Brasseler USA5032049U05032049U02026-09-25
08404535030662Brasseler USA5032050U05032050U02026-09-25
00887919673866Brasseler USA5022561U05022561U02023-01-25
00887919676201Brasseler USA5022789U05022789U02023-01-25
00887919749981Brasseler USA5025306U05025306U02023-01-25
00887919752301Brasseler USA5025362U05025362U02023-01-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D955ROWDISL1Paul BandittTerlain Enterprises, Inc.EMG2026-09-25
D955ROWDISR1Paul BandittTerlain Enterprises, Inc.EMG2026-09-25
00190776411084MillenniumAvalign Technologies, Inc.EMG2026-08-07
G879100001A0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMG2026-07-31
00190776403676MillenniumAvalign Technologies, Inc.EMG2026-07-21
00190776403232MillenniumAvalign Technologies, Inc.EMG2026-07-19
00850083275556Intrace USAPILOTIS TECH LLCEMG2026-07-03
G149TBSB7010TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7020TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7030TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7040TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7050TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7060TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7070TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7080TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7090TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7100TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7110TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7120TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7130TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7140TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7150TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7160TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7170TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7180TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7190TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7200TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7210TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7220TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7230TBS BASICSACME ENTERPRISE.EMG2026-05-21