FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD90781001000
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD9078100100
Catalog number
SD9078100100
Device description
Silicone Brain Spatula, Copper Coated Black Silicone, Malleable, Extra-Large, 11.0mm Wide
Published
2026-07-17
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
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD90781001000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical system monitor/shieldA dedicated unit designed to interface with an electrosurgical system to help detect and manage high frequency leakage of current from active electrodes used in combination with endoscopes or other instruments during endoscopic procedures (especially laparoscopic).

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
B382SD89239290Surgical DirectSD8923-929SD8923-9292026-07-17
B382SD89509290Surgical DirectSD8950-929SD8950-9292026-07-17
B382SD89529290Surgical DirectSD8952-929SD8952-9292026-07-17
B382SD89759150Surgical DirectSD8975-915SD8975-9152026-07-17
B382SD89819320Surgical DirectSD8981-932SD8981-9322026-07-17
B382SD89839280Surgical DirectSD8983-928SD8983-9282026-07-17
B382SD89839290Surgical DirectSD8983-929SD8983-9292026-07-17
B382SD89914450Surgical DirectSD8991445SD89914452026-07-17
B382SD9013461020Surgical DirectSD901346102SD9013461022026-07-17
B382SD9070791100Surgical DirectSD907079110SD9070791102026-07-17
B382SD9073531010Surgical DirectSD907353101SD9073531012026-07-17
B382SD90738400T0Surgical DirectSD90738400TSD90738400T2026-07-17
B382SD9073931130Surgical DirectSD907393113SD9073931132026-07-17
B382SD9074751070Surgical DirectSD907475107SD9074751072026-07-17
B382SD9075041030Surgical DirectSD907504103SD9075041032026-07-17
B382SD907505200Surgical DirectSD90750520SD907505202026-07-17
B382SD907505210Surgical DirectSD90750521SD907505212026-07-17
B382SD907530128T0Surgical DirectSD907530128TSD907530128T2026-07-17
B382SD907530129T0Surgical DirectSD907530129TSD907530129T2026-07-17
B382SD907573330Surgical DirectSD90757333SD907573332026-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506092176ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-17
00888867561793Arthrex®ARTHREX, INC.GCJ2026-07-17
B382SD9918100Surgical DirectSurgical Direct, Inc.GCJ2026-07-17
B382SD1184590Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD12711090Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD1271390Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD1271590Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD13018770Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD13168350Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD23373490Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD770561050Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD775011530Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD775021630Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD77505650Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD7751586C0Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD7751587C0Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
00850045863012ArthroFree® 2 ReceiverLazurite Holdings LLCGCJ2026-07-10
00850045863029ArthroFree® 2 Wireless Camera HeadLazurite Holdings LLCGCJ2026-07-10
00850045863036ArthroFree® 2 Operating Room KitLazurite Holdings LLCGCJ2026-07-10
00850045863043ArthroFree® 2 Single Camera Head SetLazurite Holdings LLCGCJ2026-07-10
B382SD883110450Surgical DirectSurgical Direct, Inc.GCJ2026-07-10
B382SD88324450Surgical DirectSurgical Direct, Inc.GCJ2026-07-10
00190776421731MillenniumAvalign Technologies, Inc.GCJ2026-06-24
00190776421663MillenniumAvalign Technologies, Inc.GCJ2026-06-23
00190776421687MillenniumAvalign Technologies, Inc.GCJ2026-06-23
00198506091506ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-10
00198506044366ELMEDELMED INCORPORATEDGCJ2026-06-09
00812231033906PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231033913PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231033920PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08