FDA.reportPublic FDA data

Brasseler USA

Primary DI
00887919414032
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5001890U0
Device description
324 SCISSOR C&C 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
EIRSCISSORS, COLLAR AND CROWN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIRScissors, Collar And CrownDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887919414032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919414032008879194140328879194140320887919414032

GMDN Terms#

Term, Definition table
TermDefinition
Dental surgical scissorsA hand-held dental instrument used to cut oral tissue during a dental surgical procedure. It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically made of high-grade stainless steel and has blades that terminate in sharp, fine, points. 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
G149TBSB71150TBS BASICSACME ENTERPRISE.EIR2026-05-22
G149TBSB71160TBS BASICSACME ENTERPRISE.EIR2026-05-22
D758SC00110RIBBOND SCISSORSRIBBOND, INCEIR2025-06-27
00359883003043Clinician's Choice® Micropoint ScissorsDEN-MAT HOLDINGS, LLCEIR2025-03-12
D105SKU1626020SurgiMac Surgimac LLCEIR2024-04-22
D105SKU1626030SurgiMac Surgimac LLCEIR2024-04-22
D105SKU1626021SurgiMac Surgimac LLCEIR2024-04-22
D105SKU1626031SurgiMac Surgimac LLCEIR2024-04-22
G586G92536210Novo SurgicalNOVO SURGICAL, INC.EIR2024-03-13
G586G2535230Novo SurgicalNOVO SURGICAL, INC.EIR2023-12-18
00841336101920Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIR2023-08-10
D758II0Ribbond ScissorsRIBBOND, INCEIR2023-07-20
00810059291683Denovo Dental stainless steel Crowns Scissors - assortmentDenovo Dental, Inc.EIR2023-06-30
00810059291690Denovo Dental Crown Scissors Denovo Dental, Inc.EIR2023-06-30
00810059291706Denovo Dental Crown Scissors Denovo Dental, Inc.EIR2023-06-30
00810059291713Denovo Dental Crown Scissors Denovo Dental, Inc.EIR2023-06-30
00840183520038BR Surgical, LLCBR Surgical, LLCEIR2023-04-26
D127242135A1Artman Instruments Wise Linkers, LLCEIR2023-03-29
D127EUDODZO1SX1Artman Instruments Wise Linkers, LLCEIR2023-03-29
E89648690SCHWERTA. Schweickhardt GmbH & Co. KGEIR2023-02-23
EZPF46683090HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEIR2022-12-16
EZPF46687100HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEIR2022-12-16
306058610691143M™3M COMPANYEIR2022-12-08
306058610691213M™3M COMPANYEIR2022-12-08
00887919414049Brasseler USAPeter Brasseler Holdings, LLCEIR2022-12-08
EZPF46674100HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEIR2022-12-07
EZPF46675100HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEIR2022-12-07
EZPF46685120HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEIR2022-12-07
EZPF4688512TC0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEIR2022-12-07
00842962110836HNM MedicalHNM STAINLESS, LLC.EIR2022-12-06