FDA.reportPublic FDA data

SurgiMac

Primary DI
D105SKU1626030
Brand
SurgiMac
Company
Surgimac LLC
Model
16-2603
Catalog number
16-2602
Device description
Goldman Fox TC, straight, Scissors, Pro Series.
Published
2024-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
D105SKU1626031PackageHIBCC100In Commercial Distribution
D105SKU1626030PrimaryHIBCC0

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.

Regulatory Flags#

DUNS number
060635048
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D105VP9008MI4MacImpressVP-9008-MIVP9008MI2026-07-06
D1051013021MacSafe10-13021013022026-06-26
D1051013031MacSafe10-13031013032026-06-26
D1051013041MacSafe10-13041013042026-06-26
D1051013011MacSafe10-13011013012026-06-25
D105VP9008MI10MacImpress VP-9008-MI-12025-11-07
D105VP9007MI2MacImpress VP-9007-MI2025-09-25
D105VP9011MI2MacImpress VP-9011-MI2025-09-25
D105VP9007MI11MacImpress VP-9007-MI-12025-09-25
D105VP9007MI21MacImpress VP-9007-MI2025-09-25
D105VP9011MI11MacImpress VP-9011-MI-12025-09-25
D105VP9011MI21MacImpress VP-9011-MI2025-09-25
D105121781MacBite121782025-08-15
D1051217840MacBite12178-42025-08-15
D105121789MacBite121782025-08-15
D1051217849MacBite12178-42025-08-15
D1057115XS0MacTouch 7115-XS2025-08-14
D1057115XSCS1MacTouch 7115-XS-CS2025-08-14
D1057116S0MacTouch 7116-S2025-08-14
D1057116SCS1MacTouch 7116-S-CS2025-08-14

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
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
00887919414032Brasseler USAPeter Brasseler Holdings, LLCEIR2022-12-08
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