FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD467030
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD46703
Catalog number
SD46703
Device description
Small Aortic Retractor Blade, For use with SD46700
Published
2026-08-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FFORETRACTOR, SELF-RETAINING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFORetractor, Self-RetainingGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD467030PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retractor/retraction system blade, reusableA distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge to separate the margins of a wound/incision during a surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is a metal device, sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle, because it is available in a variety of lengths and sizes. 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B382SD1802S90Surgical DirectSD1802S9SD1802S92026-10-13
B382SD18146S90Surgical DirectSD18146S9SD18146S92026-10-13
B382SD316490Surgical DirectSD31649SD316492026-10-13
B382SD316690Surgical DirectSD31669SD316692026-10-13
B382SD316890Surgical DirectSD31689SD316892026-10-13
B382SD4810320Surgical DirectSD48-1032SD48-10322026-10-13
B382SD482014PH0Surgical DirectSD48-2014PHSD48-2014PH2026-10-13
B382SD482036PH0Surgical DirectSD48-2036PHSD48-2036PH2026-10-13
B382SD4843590Surgical DirectSD48-4359SD48-43592026-10-13
B382SD488200810Surgical DirectSD48-820081SD48-8200812026-10-13
B382SD56300680Surgical DirectSD56300-68SD56300-682026-10-13
B382SD563006820Surgical DirectSD56300-682SD56300-6822026-10-13
B382SD9055891010Surgical DirectSD905589101SD9055891012026-10-13
B382SD9076011030Surgical DirectSD907601103SD9076011032026-10-13
B382SD030861101530Surgical DirectSD03086-11015-3SD03086-11015-32026-10-09
B382SD914636200Surgical DirectSD91463620SD914636202026-10-09
B382SD914636210Surgical DirectSD91463621SD914636212026-10-09
B382SD914636230Surgical DirectSD91463623SD914636232026-10-09
B382SD914636240Surgical DirectSD91463624SD914636242026-10-09
B382SD914700200Surgical DirectSD91470020SD914700202026-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD1802S90Surgical DirectSurgical Direct, Inc.FFO2026-10-13
B382SD9076011030Surgical DirectSurgical Direct, Inc.FFO2026-10-13
B382SD922616100Surgical DirectSurgical Direct, Inc.FFO2026-10-09
B382SD922616110Surgical DirectSurgical Direct, Inc.FFO2026-10-09
B382SD907620220Surgical DirectSurgical Direct, Inc.FFO2026-09-30
B382SD9076671330Surgical DirectSurgical Direct, Inc.FFO2026-09-29
B382SD914180130Surgical DirectSurgical Direct, Inc.FFO2026-09-29
00810238290049PRINCETONPrinceton Medical Group, Inc.FFO2026-09-22
00850088713862PRINCETONPrinceton Medical Group, Inc.FFO2026-09-22
04049047074694GimmiGimmi GmbHFFO2026-08-14
B382SD921405170Surgical DirectSurgical Direct, Inc.FFO2026-08-07
B382SD93415040Surgical DirectSurgical Direct, Inc.FFO2026-08-07
B382SD459000Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD460350Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD460360Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467000Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467010Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467020Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467040Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467050Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD48250Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD493680Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD493690Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD493770Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD6213120Surgical DirectSurgical Direct, Inc.FFO2026-08-03
00190776407483MillenniumAvalign Technologies, Inc.FFO2026-07-31
B382SD14174550Surgical DirectSurgical Direct, Inc.FFO2026-07-31
B382SD90712216T0Surgical DirectSurgical Direct, Inc.FFO2026-07-29
B382SD907581320Surgical DirectSurgical Direct, Inc.FFO2026-07-24
B382SD9075041030Surgical DirectSurgical Direct, Inc.FFO2026-07-17