FDA.reportPublic FDA data

Brasseler USA

Primary DI
00887919759645
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5025449U0
Device description
SPM20 CORN SUTURE 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
EJYPliers, operative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJYPliers, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887919759645PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919759645008879197596458879197596450887919759645

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, tweezers-like, reusableA hand-held, manual, open-surgery instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is made of high-grade stainless steel, available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. This is a reusable device intended to be sterilized prior to use.

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
G149TBSB2140TBS BASICSACME ENTERPRISE.EJY2026-05-16
G149TBSB3070TBS BASICSACME ENTERPRISE.EJY2026-05-16
G149TBSB3080TBS BASICSACME ENTERPRISE.EJY2026-05-16
G149TBSB3090TBS BASICSACME ENTERPRISE.EJY2026-05-16
07898588840032PEAK 003ZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-03-07
07898588840049PEAK 004ZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-03-07
07898588840841121ZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-03-07
07898588840902ELASTIC SETTERZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-03-07
07898588841244REPLACEMENTZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-03-07
07898588841497TRIDENT CURTO MINIZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-03-07
07898588841541TWEED OMEGA LOOP MINIZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-03-07
07898588841602V BEND MINIZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-03-07
07898588841657WEINGART MINIZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-03-07
07898588841855117 PZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-03-07
07898588842272117 IZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-03-07
07898588840223CONVENTIONAL LARGE LINGUALZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-02-25
07898588840919CONVENTIONAL LINGUALZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-02-25
07898588840964YARN SHORTZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-02-25
07898588841831CONVENTIONAL LINGUAL IOMZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-02-25
07898588841954CUT SHORTZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-02-25
07898588843484YARN SHORTZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-02-25
07898588843521BILLER CHALLENGEZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-02-25
07898588840070ABELL FOR PEDIATRIC DENTISTRYZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-02-24
07898588840155ANDREZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-02-24
07898588840858PARROT BEAKZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-02-24
07898588840872FLAT BEAKZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-02-24
07898588840889BILLER CHALLENGEZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-02-24
07898588841756MODIFIED ANDREZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-02-24
07898588841763301 AIG 301ZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-02-24
07898588841770AIG 401ZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-02-24