FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD921301020
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD92130102
Catalog number
SD92130102
Device description
5 3/4 inch Joseph Nasal Knife, Curved Double Sided Blade
Published
2022-12-01
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
GEGELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEGElevator, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD921301020PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone lever/elevator, reusableA manual surgical instrument designed to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. It is made of high-grade stainless steel and is available in a wide variety of sizes, designs, and blade shapes. It is typically a robust instrument with a blunted blade with no cutting edge at the distal end that can be pointed, rounded, flat, curved or hook shaped and a handle of various designs at the proximal end. Some types can have special functions, e.g., for angle joint operations or for luxation procedures. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 (800) 519-3293info@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
B382SD512531140Surgical DirectSD51253114SD512531142026-02-03
B382SD77321140Surgical DirectSD7732114SD77321142026-02-03
B382SD97321140Surgical DirectSD9732114SD97321142026-02-02
B382SD97321150Surgical DirectSD9732115SD97321152026-02-02
B382SD97331160Surgical DirectSD9733116SD97331162026-02-02
B382SD51531140Surgical DirectSD5153114SD51531142025-12-02
B382SD65331140Surgical DirectSD6533114SD65331142025-12-02
B382SD67511170Surgical DirectSD6751117SD67511172025-06-04
B382SD95321140Surgical DirectSD9532114SD95321142025-06-04
B382SD84531130Surgical DirectSD8453113SD84531132025-04-03
B382SD92422150Surgical DirectSD9242215SD92422152025-03-17
B382SD512531150Surgical DirectSD51253115SD512531152025-03-10
B382SD123200Surgical DirectSD12320SD123202024-12-12
B382SD52321110Surgical DirectSD5232111SD52321112024-08-08
B382SD82421110Surgical DirectSD8242111SD82421112024-08-01
B382SD81531140Surgical DirectSD8153114SD81531142024-03-12
B382SD82131160Surgical DirectSD8213116SD82131162024-03-12
B382SD42531170Surgical DirectSD4253117SD42531172024-02-23
B382SD4810450Surgical DirectSD481045SD4810452024-01-31
B382SD77311150Surgical DirectSD7731115SD77311152023-06-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810220800102Adler Instrument CompanyAdler, Inc.GEG2026-05-26
00190776417987MillenniumAvalign Technologies, Inc.GEG2026-03-23
00190776417536MillenniumAvalign Technologies, Inc.GEG2026-02-27
B382SD9141051070Surgical DirectSurgical Direct, Inc.GEG2026-02-17
00190776416577MillenniumAvalign Technologies, Inc.GEG2026-02-16
B382SD62432250Surgical DirectSurgical Direct, Inc.GEG2026-02-16
B382SD9141051050Surgical DirectSurgical Direct, Inc.GEG2026-02-16
B382SD23020Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD23030Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD671050Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD6716050Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD9141051060Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD9141051080Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD9206611040Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD921316170Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD921381050Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD92263910000Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD9226411030Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD922658020Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD923862510Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD940111100Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD1467010200Surgical DirectSurgical Direct, Inc.GEG2026-02-06
B382SD481003700Surgical DirectSurgical Direct, Inc.GEG2026-02-06
B382SD48820100Surgical DirectSurgical Direct, Inc.GEG2026-02-06
G3831056WM853543SURJEXSURJEXGEG2026-01-31
00190776415501MillenniumAvalign Technologies, Inc.GEG2026-01-27
00810123209743Adler Instrument CompanyAdler, Inc.GEG2026-01-02
00841336106802Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCGEG2025-12-22
00841336106819Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCGEG2025-12-22
B382SD91010Surgical DirectSurgical Direct, Inc.GEG2025-12-02