FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD493680
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD49368
Catalog number
SD49368
Device description
1/2" Upright for Port System
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
B382SD493680PrimaryHIBCC0

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
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
B382SD922616100Surgical DirectSD92261610SD922616102026-10-09
B382SD922616110Surgical DirectSD92261611SD922616112026-10-09
B382SD922682100Surgical DirectSD92268210SD922682102026-10-09
B382SD922779120Surgical DirectSD92277912SD922779122026-10-09
B382SD9228051950Surgical DirectSD922805195SD9228051952026-10-09
B382SD939422110Surgical DirectSD93942211SD939422112026-10-09
B382SD9030741020Surgical DirectSD903074102SD9030741022026-10-08
B382SD907019950Surgical DirectSD90701995SD907019952026-10-08
B382SD9071922050Surgical DirectSD907192205SD9071922052026-10-08
B382SD911160330Surgical DirectSD91116033SD911160332026-10-08
B382SD915039160Surgical DirectSD91503916SD915039162026-10-08
B382SD918660100Surgical DirectSD91866010SD918660102026-10-08
B382SD922616030Surgical DirectSD92261603SD922616032022-12-01
B382SD6713210Surgical DirectSD67-1321SD67-13212026-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
B382SD467030Surgical 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
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
B382SD907530128T0Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD907530129T0Surgical DirectSurgical Direct, Inc.FFO2026-07-17