FDA.reportPublic FDA data

SurgiMac

Primary DI
D105SKU104580
Brand
SurgiMac
Company
Surgimac LLC
Model
10-458
Catalog number
10-458
Device description
College Cotton pliers, 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
EFLForceps, Dressing, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFLForceps, Dressing, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D105SKU104581PackageHIBCC100In Commercial Distribution
D105SKU104580PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental dressing forceps, reusableA hand-held manual dental instrument designed for grasping and holding a dental dressing during its application to a patient's oral cavity. It typically has a tweezers-like design with two conjoined blades with serrated tips at the working end. It is made of high-grade stainless steel and is available in various sizes. 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
00190776400279MillenniumAvalign Technologies, Inc.EFL2026-07-17
00850083275525Intrace USAPILOTIS TECH LLCEFL2026-07-03
05060212051264College Dental Forceps 160mmDTR MEDICAL LIMITEDEFL2026-06-10
B382S28531030Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382S28531040Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382S2853252T0Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382S285401100Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD902172106T0Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD9023191000Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD9027351020Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD9028531080Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD9028531260Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD9028531290Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD9028531720Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD9028541100Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD9028541170Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD902861100T0Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD902869400Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD902870110Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD902991101T0Surgical DirectSurgical Direct, Inc.EFL2026-06-08
G149TBSB7960TBS BASICSACME ENTERPRISE.EFL2026-05-22
G149TBSB7970TBS BASICSACME ENTERPRISE.EFL2026-05-22
G149TBSB7980TBS BASICSACME ENTERPRISE.EFL2026-05-22
G149NP380750NPSACME ENTERPRISE.EFL2026-05-01
G149NPRMF0NPSACME ENTERPRISE.EFL2026-05-01
00371347023503Advance Dental ProductsThe Atlanta Dental Supply CompanyEFL2026-04-14
ESAM3851141STOMA®Storz am Mark GmbHEFL2026-03-25
B382S2511200Surgical DirectSurgical Direct, Inc.EFL2026-03-09
B382S2548010Surgical DirectSurgical Direct, Inc.EFL2026-03-09
B382S2548020Surgical DirectSurgical Direct, Inc.EFL2026-03-09