FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD493291200
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD49329-120
Catalog number
SD49329-120
Device description
"9"" Vascular Graft Tunneler, Curved 120 Degree with Handle 6mm"
Published
2025-06-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GENForceps, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD493291200PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Vascular graft tunnellerA long, surgical instrument used to tunnel an artificial passageway along vascular tissue planes to create a connecting channel typically for the introduction of a vascular graft or a vascular prosthesis. It can have a variety of designs, but basically it will be a long, round, stiff rod that tapers to a rounded point at the distal tip and have a handle at the proximal end to allow the surgeon to exert the necessary pressure and manipulation to push it through the body tissue. It will typically be made of high-grade stainless steel and possibly other materials for the handle, which may be detachable. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(386) 738-1202info@surgicaldirect.com

Regulatory Flags#

DUNS number
124367223
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B382S8711000Surgical DirectS871.100S871.1002026-07-14
B382S8711010Surgical DirectS871.101S871.1012026-07-14
B382S8711020Surgical DirectS871.102S871.1022026-07-14
B382SD08890310101D0Surgical DirectSD08890-31010-1DSD08890-31010-1D2026-07-14
B382SD08890320101D0Surgical DirectSD08890-32010-1DSD08890-32010-1D2026-07-14
B382SD1184590Surgical DirectSD118459SD1184592026-07-14
B382SD123750Surgical DirectSD12375SD123752026-07-14
B382SD123760Surgical DirectSD12376SD123762026-07-14
B382SD123780Surgical DirectSD12378SD123782026-07-14
B382SD124326191140Surgical DirectSD12432-619-114SD12432-619-1142026-07-14
B382SD12711090Surgical DirectSD1271-109SD1271-1092026-07-14
B382SD1271390Surgical DirectSD1271-39SD1271-392026-07-14
B382SD1271590Surgical DirectSD1271-59SD1271-592026-07-14
B382SD13018770Surgical DirectSD13018-77SD13018-772026-07-14
B382SD13024290Surgical DirectSD1302.429SD1302.4292026-07-14
B382SD13168350Surgical DirectSD13168-35SD13168-352026-07-14
B382SD209910FSANT0Surgical DirectSD209910-FS-AN-TSD209910-FS-AN-T2026-07-14
B382SD209920FSANT0Surgical DirectSD209920-FS-AN-TSD209920-FS-AN-T2026-07-14
B382SD209923FSANT0Surgical DirectSD209923-FS-AN-TSD209923-FS-AN-T2026-07-14
B382SD2303290Surgical DirectSD230329SD2303292026-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776397050MillenniumAvalign Technologies, Inc.GEN2026-07-16
00190776398651MillenniumAvalign Technologies, Inc.GEN2026-07-16
B382SD914264010Surgical DirectSurgical Direct, Inc.GEN2026-07-13
00850083275075Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275082Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275099Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275105Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275112Intrace USAPILOTIS TECH LLCGEN2026-07-03
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00860015282088Intrace USAPILOTIS TECH LLCGEN2026-07-03
00190776421656MillenniumAvalign Technologies, Inc.GEN2026-06-23
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