FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD493690
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD49369
Catalog number
SD49369
Device description
5/8" 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
B382SD493690PrimaryHIBCC0

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
B382SD13517450Surgical DirectSD 1351745SD 13517452026-10-28
B382SD13518130Surgical DirectSD13518-13SD13518-132026-10-28
B382SD15908130Surgical DirectSD15908-13SD15908-132026-10-28
B382SD161310590Surgical DirectSD16131059SD161310592026-10-28
B382SD48310090Surgical DirectSD48-31009SD48-310092026-10-28
B382SD4865700Surgical DirectSD48-6570SD48-65702026-10-28
B382SD6200420Surgical DirectSD62-0042SD62-00422026-10-28
B382SD6200430Surgical DirectSD62-0043SD62-00432026-10-28
B382SD62372600Surgical DirectSD62-37260SD62-372602026-10-28
B382SD62372610Surgical DirectSD62-37261SD62-372612026-10-28
B382SD62372620Surgical DirectSD62-37262SD62-372622026-10-28
B382SD62372700Surgical DirectSD62-37270SD62-372702026-10-28
B382SD62372710Surgical DirectSD62-37271SD62-372712026-10-28
B382SD62372720Surgical DirectSD62-37272SD62-372722026-10-28
B382SD62373320Surgical DirectSD62-37332SD62-373322026-10-28
B382SD62373340Surgical DirectSD62-37334SD62-373342026-10-28
B382SD62373360Surgical DirectSD62-37336SD62-373362026-10-28
B382SD67371410Surgical DirectSD67-37141SD67-371412026-10-28
B382SD6787200Surgical DirectSD67-8720SD67-87202026-10-28
B382SD77505940Surgical DirectSD77505-94SD77505-942026-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD907234170Surgical DirectSurgical Direct, Inc.FFO2026-10-22
B382SD48800050Surgical DirectSurgical Direct, Inc.FFO2026-10-15
B382SD717510050Surgical DirectSurgical Direct, Inc.FFO2026-10-15
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
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
B382SD493680Surgical 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