FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD92422150
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD9242215
Catalog number
SD9242215
Device description
4.8mm 8' Autoclavable Fiber Light Cable, Light Source Type: Karl Storz, Scope Type: ACMI/Circon, Eder, KLI, Luxtec, Stryker, Wehmer, Welch Allyn, Zeiss Zimmer, Snap On, Angled, Light Blue
Published
2025-03-17
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
B382SD92422150PrimaryHIBCC0

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 Diameter4.25Millimeter

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
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
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
B382SD97331160Surgical 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
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