FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD90401003E0
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD90401003E
Catalog number
SD90401003E
Device description
#3 Knife Handle, Ebonized
Published
2024-02-28
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
GDZHandle, Scalpel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDZHandle, ScalpelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD90401003E0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel handle, reusableA device that is an interchangeable component of a scalpel and that functions as a handle designed to mount a compatible blade. This device with the blade become a single-bladed surgical instrument intended to be used by a physician for cutting or dissecting tissue. The device is typically made of metal (e.g., stainless steel or brass). 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
B382SD9207261140Surgical DirectSD920726114SD9207261142022-12-05
B382SD905500140Surgical DirectSD90550014SD905500142022-11-30
B382SD017210000Surgical DirectSD0172-1000SD0172-10002026-08-21
B382SD13448970Surgical DirectSD13448-97SD13448-972026-08-21
B382SD16008970Surgical DirectSD16008-97SD16008-972026-08-21
B382SD161730Surgical DirectSD1617-3SD1617-32026-08-21
B382SD3028P0Surgical DirectSD3028PSD3028P2026-08-21
B382SD77205052000Surgical DirectSD77205-05-200SD77205-05-2002026-08-21
B382SD77205082000Surgical DirectSD77205-08-200SD77205-08-2002026-08-21
B382SD7720508TS2000Surgical DirectSD77205-08TS-200SD77205-08TS-2002026-08-21
B382SD77205252000Surgical DirectSD77205-25-200SD77205-25-2002026-08-21
B382SD83042110011NS0Surgical DirectSD83042-11001-1NSSD83042-11001-1NS2026-08-21
B382SD9017971000Surgical DirectSD901797100SD9017971002026-08-21
B382SD907300000Surgical DirectSD90730000SD907300002026-08-21
B382SD914775290Surgical DirectSD91477529SD914775292026-08-21
B382SD915039080Surgical DirectSD91503908SD915039082026-08-21
B382SD915039140Surgical DirectSD91503914SD915039142026-08-21
B382SD915039150Surgical DirectSD91503915SD915039152026-08-21
B382SD9227656000Surgical DirectSD922765600SD9227656002026-08-21
B382SD9144941010Surgical DirectSD914494101SD9144941012026-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995267742Snowden-PencerSTERIS Deutschland GmbHGDZ2026-09-25
D955BLAHST1Paul BandittTerlain Enterprises, Inc.GDZ2026-09-25
00724995267728Snowden-PencerSTERIS Deutschland GmbHGDZ2026-09-24
00190776429072MillenniumAvalign Technologies, Inc.GDZ2026-09-04
00724995314682V. MuellerSteris CorporationGDZ2026-08-21
00724995314699V. MuellerSteris CorporationGDZ2026-08-21
00724995314705V. MuellerSteris CorporationGDZ2026-08-21
00724995314712V. MuellerSteris CorporationGDZ2026-08-21
00724995314729V. MuellerSteris CorporationGDZ2026-08-21
00724995317362V. MuellerSteris CorporationGDZ2026-08-21
00724995317379V. MuellerSteris CorporationGDZ2026-08-21
00724995320492V. MuellerSteris CorporationGDZ2026-08-21
00724995320508V. MuellerSteris CorporationGDZ2026-08-21
00724995320515V. MuellerSteris CorporationGDZ2026-08-21
00724995320522V. MuellerSteris CorporationGDZ2026-08-21
00724995320539V. MuellerSteris CorporationGDZ2026-08-21
00724995343446V. MuellerSteris CorporationGDZ2026-08-21
04054462913466evonosevonos GmbH & Co. KGGDZ2026-08-19
04054462913473evonosevonos GmbH & Co. KGGDZ2026-08-19
04054462913480evonosevonos GmbH & Co. KGGDZ2026-08-19
04054462913527evonosevonos GmbH & Co. KGGDZ2026-08-19
00190776422837MillenniumAvalign Technologies, Inc.GDZ2026-08-03
07613327651188VersiQuadSTRYKER CORPORATIONGDZ2026-07-22
00190776396800MillenniumAvalign Technologies, Inc.GDZ2026-07-14
00850083275563Intrace USAPILOTIS TECH LLCGDZ2026-07-03
00810055255689Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055255696Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055255702Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055255726Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055255788Surgical DesignSurgical Design, Inc.GDZ2026-06-26