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
B382SD491118070Surgical DirectSD49-111807SD49-1118072026-10-22
B382SD77105560Surgical DirectSD77105-56SD77105-562026-10-22
B382SD772553050Surgical DirectSD77255-305SD77255-3052026-10-22
B382SD90120123T0Surgical DirectSD90120123TSD90120123T2026-10-22
B382SD9012101000Surgical DirectSD901210100SD9012101002026-10-22
B382SD901229040Surgical DirectSD90122904SD901229042026-10-22
B382SD9012941000Surgical DirectSD901294100SD9012941002026-10-22
B382SD901294100T0Surgical DirectSD901294100TSD901294100T2026-10-22
B382SD9012981000Surgical DirectSD901298100SD9012981002026-10-22
B382SD901345140Surgical DirectSD90134514SD901345142026-10-22
B382SD901365200Surgical DirectSD90136520SD901365202026-10-22
B382SD9015171000Surgical DirectSD901517100SD9015171002026-10-22
B382SD9015171010Surgical DirectSD901517101SD9015171012026-10-22
B382SD90190030Surgical DirectSD9019003SD90190032026-10-22
B382SD902508010Surgical DirectSD90250801SD902508012026-10-22
B382SD902508030Surgical DirectSD90250803SD902508032026-10-22
B382SD907234170Surgical DirectSD90723417SD907234172026-10-22
B382SD9147211110Surgical DirectSD914721111SD9147211112026-10-22
B382SD9147211120Surgical DirectSD914721112SD9147211122026-10-22
B382SD9147211130Surgical DirectSD914721113SD9147211132026-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250337121961Biopsy Forceps, SpoonJoimax GmbHGEN2026-10-26
04250337121978Biopsy Forceps, Spoon, angledJoimax GmbHGEN2026-10-26
00198506095863ELMED INCORPORATEDELMED INCORPORATEDGEN2026-10-23
00198506096310ELMED INCORPORATEDELMED INCORPORATEDGEN2026-10-23
00190776435646MillenniumAvalign Technologies, Inc.GEN2026-10-21
00190776435691MillenniumAvalign Technologies, Inc.GEN2026-10-21
00190776435745MillenniumAvalign Technologies, Inc.GEN2026-10-21
00190776436780MillenniumAvalign Technologies, Inc.GEN2026-10-21
00190776436810MillenniumAvalign Technologies, Inc.GEN2026-10-21
00190776435448MillenniumAvalign Technologies, Inc.GEN2026-10-19
00840329838669N/ABLACK & BLACK SURGICAL, INC.GEN2026-10-15
00190776435011MillenniumAvalign Technologies, Inc.GEN2026-10-14
00190776435035MillenniumAvalign Technologies, Inc.GEN2026-10-14
00190776434816MillenniumAvalign Technologies, Inc.GEN2026-10-13
00190776434779MillenniumAvalign Technologies, Inc.GEN2026-10-12
04058749012842NAFehling Instruments GmbH & Co. KGGEN2026-10-12
00190776434175MillenniumAvalign Technologies, Inc.GEN2026-10-09
00198506095801ELMED INCORPORATEDELMED INCORPORATEDGEN2026-10-09
00198506095818ELMED INCORPORATEDELMED INCORPORATEDGEN2026-10-09
00198506095825ELMED INCORPORATEDELMED INCORPORATEDGEN2026-10-09
00198506095832ELMED INCORPORATEDELMED INCORPORATEDGEN2026-10-09
00840314252449gSourceGSOURCE LLCGEN2026-10-09
00190776436605MilleniumAvalign Technologies, Inc.GEN2026-10-08
00190776433604MillenniumAvalign Technologies, Inc.GEN2026-10-07
00190776434380MillenniumAvalign Technologies, Inc.GEN2026-10-07
B382SD6713210Surgical DirectSurgical Direct, Inc.GEN2026-10-07
B382SD6713290Surgical DirectSurgical Direct, Inc.GEN2026-10-07
B382SD6520450Surgical DirectSurgical Direct, Inc.GEN2026-10-06
B382SD6562120Surgical DirectSurgical Direct, Inc.GEN2026-10-06
00190776433048MillenniumAvalign Technologies, Inc.GEN2026-10-01