FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD20260
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD2-026
Catalog number
SD2-026
Device description
All Channel Irrigator, for SD Scopes
Published
2026-08-03
Public version status
New
Distribution status
Not 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
OCXEndoscopic Irrigation/Suction System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCXEndoscopic Irrigation/Suction SystemGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD20260PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope sheath, reusableA component of a rigid or flexible endoscope assembly designed as a tube through which an endoscope (e.g., hysteroscope) and endoscopic elements are introduced and assembled to create a complete operative endoscopic unit; it is also designed to function as a protective barrier to isolate the endoscope from patient contact and prevent contamination of the endoscope controls during a procedure. It typically contains ports to enable the insertion of instruments (through the endoscope or through independent working channels), insufflation ports, valves and connectors. It is made of plastic and metal materials. 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
B382SD491118070Surgical DirectSD49-111807SD49-1118072026-10-22
B382SD77105560Surgical DirectSD77105-56SD77105-562026-10-22
B382SD772553050Surgical DirectSD77255-305SD77255-3052026-10-22
B382SD90120123T0Surgical DirectSD90120123TSD90120123T2026-10-22
B382SD9012101000Surgical DirectSD901210100SD9012101002026-10-22
B382SD901229040Surgical DirectSD90122904SD901229042026-10-22
B382SD9012941000Surgical DirectSD901294100SD9012941002026-10-22
B382SD901294100T0Surgical DirectSD901294100TSD901294100T2026-10-22
B382SD9012981000Surgical DirectSD901298100SD9012981002026-10-22
B382SD901345140Surgical DirectSD90134514SD901345142026-10-22
B382SD901365200Surgical DirectSD90136520SD901365202026-10-22
B382SD9015171000Surgical DirectSD901517100SD9015171002026-10-22
B382SD9015171010Surgical DirectSD901517101SD9015171012026-10-22
B382SD90190030Surgical DirectSD9019003SD90190032026-10-22
B382SD902508010Surgical DirectSD90250801SD902508012026-10-22
B382SD902508030Surgical DirectSD90250803SD902508032026-10-22
B382SD907234170Surgical DirectSD90723417SD907234172026-10-22
B382SD9147211110Surgical DirectSD914721111SD9147211112026-10-22
B382SD9147211120Surgical DirectSD914721112SD9147211122026-10-22
B382SD9147211130Surgical DirectSD914721113SD9147211132026-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936603212301Clean Connecting TubeYangzhou Fartley Medical Instrument Technology Co., LtdOCX2026-10-22
06936603212318Clean Connecting TubeYangzhou Fartley Medical Instrument Technology Co., LtdOCX2026-10-22
06936603212424Clean Connecting TubeYangzhou Fartley Medical Instrument Technology Co., LtdOCX2026-10-22
06936603212448Clean Connecting TubeYangzhou Fartley Medical Instrument Technology Co., LtdOCX2026-10-22
06936603212462Clean Connecting TubeYangzhou Fartley Medical Instrument Technology Co., LtdOCX2026-10-22
06936603212479Clean Connecting TubeYangzhou Fartley Medical Instrument Technology Co., LtdOCX2026-10-22
04580826928413PENTAX MedicalPENTAX MEDICAL CORPORATIONOCX2026-08-25
00884450457535C2 CryoBalloon™Merit Medical Systems, Inc.OCX2026-08-17
08809327356133ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356140ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356157ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356164ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356171ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356188ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356195ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
M84921890CleanCapture Aspiration CatheterHOBBS MEDICAL, INC.OCX2026-01-14
04953170465277AUXILIARY WATER TUBEOLYMPUS MEDICAL SYSTEMS CORP.OCX2025-12-05
M710TCW51000Bayou™ troCarWash System Disposable KitBIOTEX, INC.OCX2025-10-10
14953170458429SINGLE USE BIOPSY VALVEOLYMPUS MEDICAL SYSTEMS CORP.OCX2025-09-30
00724995232177Fuji 700 4-piece Valve KitUS EndoscopyOCX2025-05-29
00850025860901CO2 Source Tubing Filter Adapter OlympusMicro-tech UsaOCX2025-05-12
00858276007977CO2 Source Tubing Filter OlympusMicro-tech UsaOCX2025-05-12
04048551411704NAKarl Storz GmbH & Co. KGOCX2025-03-27
00850025860420Irrigation Tubing SetMicro-tech UsaOCX2025-03-07
00850025860390Air/Water Bottle CO2 TubingMicro-tech UsaOCX2025-03-04
00850025860451Air/Water Bottle TubingMicro-tech UsaOCX2025-03-04
00850025860772Air/Water Bottle TubingMicro-tech UsaOCX2025-03-04
00850025860789Air/Water Bottle CO2 TubingMicro-tech UsaOCX2025-03-04
00850025860796Irrigation Tubing SetMicro-tech UsaOCX2025-03-04
00850025860840Irrigation Tubing SetMicro-tech UsaOCX2025-03-04