FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD1427620000
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD14276-2000
Catalog number
SD14276-2000
Device description
"22 1/2"" Pin Cutter, Double Action, Side Cutting, Detachable Handles, Max Capacity 6.35mm"
Published
2023-12-26
Public version status
Update
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
B382SD1427620000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
ENT wire-cutting scissorsA hand-held manual surgical instrument designed to cut wire intended to construct ossicular replacements for the middle ear. The cutting blades will be more robust than ordinary scissors to tolerate the forces required to cut surgical wire. 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
B382SD9141791080Surgical DirectSD914179108SD9141791082024-03-29
B382SD48820700Surgical DirectSD48-82070SD48-820702023-05-24
B382SD48820070Surgical DirectSD48-82007SD48-820072022-12-02
B382SD48820080Surgical DirectSD48-82008SD48-820082022-12-02
B382SD48820090Surgical DirectSD48-82009SD48-820092022-12-02
B382SD9142211010Surgical DirectSD914221101SD9142211012022-11-30
B382S28531030Surgical DirectS2853.103S2853.1032026-06-08
B382S28531040Surgical DirectS2853.104S2853.1042026-06-08
B382S2853252T0Surgical DirectS2853.252TS2853.252T2026-06-08
B382S285401100Surgical DirectS2854.110S2854.1102026-06-08
B382SD902172106T0Surgical DirectSD902172106TSD902172106T2026-06-08
B382SD9023191000Surgical DirectSD902319100SD9023191002026-06-08
B382SD9027351020Surgical DirectSD902735102SD9027351022026-06-08
B382SD9028531080Surgical DirectSD902853108SD9028531082026-06-08
B382SD9028531260Surgical DirectSD902853126SD9028531262026-06-08
B382SD9028531290Surgical DirectSD902853129SD9028531292026-06-08
B382SD9028531720Surgical DirectSD902853172SD9028531722026-06-08
B382SD9028541100Surgical DirectSD902854110SD9028541102026-06-08
B382SD9028541170Surgical DirectSD902854117SD9028541172026-06-08
B382SD902861100T0Surgical DirectSD902861100TSD902861100T2026-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00850083275129Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275136Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275143Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275280Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275310Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275334Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275358Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275440Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275471Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275495Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275600Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275723Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275846Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275938Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275976Intrace USAPILOTIS TECH LLCGEN2026-07-03
00860015282088Intrace USAPILOTIS TECH LLCGEN2026-07-03
00198506091476ELMED INCORPORATEDELMED INCORPORATEDGEN2026-06-09
00810189451506Surgical DesignSurgical Design, Inc.GEN2026-06-06
00198506091230ELMED INCORPORATEDELMED INCORPORATEDGEN2026-06-03
G383S1061WM1413S3SURJEXSURJEXGEN2026-05-31
G383S1061WM3240913SURJEXSURJEXGEN2026-05-31
G383WM3241113SURJEXSURJEXGEN2026-05-31
00810055250929Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810055250936Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810055250943Surgical DesignSurgical Design, Inc.GEN2026-05-29