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
00887919170488Brasseler USA Sterile Carbide000388SP000388SP2026-05-27
00887919227335Brasseler USA Sterile Diamond004878SP004878SP2026-05-27
00887919317036Brasseler USA Sterile Diamond017274SP017274SP2026-05-27
08404535029468Brasseler USA Sterile Diamond004164SP004164SP2026-05-27
08404535029499Brasseler USA Sterile Diamond004325SP004325SP2026-05-27
08404535029529Brasseler USA Sterile Diamond004529SP004529SP2026-05-27
08404535029550Brasseler USA Sterile Diamond004801SP004801SP2026-05-27
08404535029581Brasseler USA Sterile Diamond004818SP004818SP2026-05-27
08404535029611Brasseler USA Sterile Diamond004820SP004820SP2026-05-27
08404535029642Brasseler USA Sterile Diamond004868SP004868SP2026-05-27
08404535029673Brasseler USA Sterile Diamond004959SP004959SP2026-05-27
08404535029703Brasseler USA Sterile Diamond005034SP005034SP2026-05-27
08404535029734Brasseler USA Sterile Diamond005043SP005043SP2026-05-27
08404535029765Brasseler USA Sterile Diamond005046SP005046SP2026-05-27
08404535029796Brasseler USA Sterile Diamond005056SP005056SP2026-05-27
08404535029826Brasseler USA Sterile Diamond005255SP005255SP2026-05-27
08404535029857Brasseler USA Sterile Diamond005256SP005256SP2026-05-27
08404535029888Brasseler USA Sterile Diamond005372SP005372SP2026-05-27
08404535029918Brasseler USA Sterile Diamond012223SP012223SP2026-05-27
08404535029949Brasseler USA Sterile Diamond013287SP013287SP2026-05-27

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