FDA.reportPublic FDA data

Brasseler USA

Primary DI
00887919413370
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5001820U0
Device description
151 SER 151-SR FORCEP 1P
Published
2022-12-08
Public version status
Update
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
00887919413370PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919413370008879194133708879194133700887919413370

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
08404535023398Brasseler USA5031885U05031885U02026-05-13
08404535029406Brasseler USA5032304U05032304U02026-05-13
08404535029437Brasseler USA5032305U05032305U02026-05-13
08404535025101Brasseler USA5032020U05032020U02026-05-11
08404535025927Brasseler USA5032032U05032032U02026-05-01
08404535015003Brasseler USA5031791U05031791U02026-04-29
08404535015126Brasseler USA5031795U05031795U02026-04-29
08404535018929Brasseler USA5031818U05031818U02026-04-29
08404535018950Brasseler USA5031819U05031819U02026-04-29
08404535019049Brasseler USA5031822U05031822U02026-04-29
08404535019070Brasseler USA5031823U05031823U02026-04-29
08404535019100Brasseler USA5031824U05031824U02026-04-29
08404535019131Brasseler USA5031825U05031825U02026-04-29
08404535019162Brasseler USA5031826U05031826U02026-04-29
08404535024227Axiom BladesBRAXM-GP8BRAXM-GP82026-04-29
08404535024258Axiom BladesBRAXM-FP14MBRAXM-FP14M2026-04-29
08404535024289Axiom BladesBRAXM-FC6BRAXM-FC62026-04-29
08404535024319Axiom BladesBRAXM-FP8SBRAXM-FP8S2026-04-29
08404535024340Axiom BladesBRAXM-HP8SBRAXM-HP8S2026-04-29
08404535024371Axiom BladesBRAXM-HP8MBRAXM-HP8M2026-04-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
G149TBSB7240TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7250TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7260TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7270TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7280TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7290TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7310TBS BASICSACME ENTERPRISE.EMG2026-05-21