FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD97331160
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD9733116
Catalog number
SD9733116
Device description
3.8mm 10' Autoclavable Pink Fiber Light Cable, Light Source Type: Storz, Scope Type: Pilling
Published
2026-02-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FFSImage, Illumination, Fiberoptic, For Endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFSImage, Illumination, Fiberoptic, For Endoscope Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K021931000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K021931000ENDOSCOPIC FIBEROPTIC CABLEGulf Medical Fiberoptics2002-09-06HBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD97331160PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Fibreoptic light cableA flexible fibreoptic cable that is designed to transport cold light from a light source to an instrument or other equipment, e.g., an endoscope or a headlight. The fibreoptic bundle is protected within a sheath and can be made of either glass or plastic fibres. Each end of the cable is encased in a metal connector that fits into the respective instruments/equipment and also protects the end of the fibreoptic bundle. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length10Feet
Outer Diameter5Millimeter

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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B382SD9141791400Surgical DirectSD914179140SD9141791402026-07-13
B382SD9142211000Surgical DirectSD914221100SD9142211002026-07-13
B382SD914264010Surgical DirectSD91426401SD914264012026-07-13
B382SD914341100Surgical DirectSD91434110SD914341102026-07-13
B382SD9143681000Surgical DirectSD914368100SD9143681002026-07-13
B382SD91705515T0Surgical DirectSD91705515TSD91705515T2026-07-13
B382SD91705525T0Surgical DirectSD91705525TSD91705525T2026-07-13
B382SD9176201020Surgical DirectSD917620102SD9176201022026-07-13
B382SD918006150Surgical DirectSD91800615SD918006152026-07-13
B382SD918006200Surgical DirectSD91800620SD918006202026-07-13
B382SD918174150Surgical DirectSD91817415SD918174152026-07-13
B382SD9183701030Surgical DirectSD918370103SD9183701032026-07-13
B382SD9183761030Surgical DirectSD918376103SD9183761032026-07-13
B382SD9184571000Surgical DirectSD918457100SD9184571002026-07-13
B382SD9184932000Surgical DirectSD918493200SD9184932002026-07-13
B382SD9153301000Surgical DirectSD915330100SD9153301002022-12-05
B382SD883110450Surgical DirectSD88311045SD883110452026-07-10
B382SD88324450Surgical DirectSD8832445SD88324452026-07-10
B382SD9032161000Surgical DirectSD903216100SD9032161002026-07-10
B382SD90390213SC0Surgical DirectSD90390213SCSD90390213SC2026-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD512531140Surgical DirectSurgical Direct, Inc.FFS2026-02-03
B382SD77321140Surgical DirectSurgical Direct, Inc.FFS2026-02-03
B382SD97321140Surgical DirectSurgical Direct, Inc.FFS2026-02-02
B382SD97321150Surgical DirectSurgical Direct, Inc.FFS2026-02-02
B382SD51531140Surgical DirectSurgical Direct, Inc.FFS2025-12-02
B382SD65331140Surgical DirectSurgical Direct, Inc.FFS2025-12-02
B382SD67511170Surgical DirectSurgical Direct, Inc.FFS2025-06-04
B382SD95321140Surgical DirectSurgical Direct, Inc.FFS2025-06-04
B382SD84531130Surgical DirectSurgical Direct, Inc.FFS2025-04-03
B382SD92422150Surgical DirectSurgical Direct, Inc.FFS2025-03-17
B382SD512531150Surgical DirectSurgical Direct, Inc.FFS2025-03-10
00857580006829Fiber Optic Light CableGULF FIBEROPTICS, INC.FFS2025-02-26
B382SD123200Surgical DirectSurgical Direct, Inc.FFS2024-12-12
00821925008892GYRUS ACMI, INCGyrus ACMI, LLCFFS2024-11-25
00857580006812Fiber Optic Light CableGULF FIBEROPTICS, INC.FFS2024-10-15
B382SD52321110Surgical DirectSurgical Direct, Inc.FFS2024-08-08
B382SD82421110Surgical DirectSurgical Direct, Inc.FFS2024-08-01
00857580006805Fiber Optic Light CableGULF FIBEROPTICS, INC.FFS2024-06-07
B382SD81531140Surgical DirectSurgical Direct, Inc.FFS2024-03-12
B382SD82131160Surgical DirectSurgical Direct, Inc.FFS2024-03-12
B382SD42531170Surgical DirectSurgical Direct, Inc.FFS2024-02-23
B382SD4810450Surgical DirectSurgical Direct, Inc.FFS2024-01-31
B382SD77311150Surgical DirectSurgical Direct, Inc.FFS2023-06-06
B382SD28130Surgical DirectSurgical Direct, Inc.FFS2023-05-16
B382SD57531150Surgical DirectSurgical Direct, Inc.FFS2023-05-08
B382SD81531120Surgical DirectSurgical Direct, Inc.FFS2023-04-24
B382SD3544140Surgical DirectSurgical Direct, Inc.FFS2023-04-06
B382SD91531140Surgical DirectSurgical Direct, Inc.FFS2023-04-06
00857580006782Fiber Optic Light CableGULF FIBEROPTICS, INC.FFS2023-03-06
00857580006799Fiber Optic Light CableGULF FIBEROPTICS, INC.FFS2023-03-06