FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD123200
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD12320
Catalog number
SD12320
Device description
10` Fiber Optic Cable with Universal Instrument and Light Source Connection
Published
2024-12-12
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
B382SD123200PrimaryHIBCC0

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 Diameter4.8Millimeter

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
B382S8711000Surgical DirectS871.100S871.1002026-07-14
B382S8711010Surgical DirectS871.101S871.1012026-07-14
B382S8711020Surgical DirectS871.102S871.1022026-07-14
B382SD08890310101D0Surgical DirectSD08890-31010-1DSD08890-31010-1D2026-07-14
B382SD08890320101D0Surgical DirectSD08890-32010-1DSD08890-32010-1D2026-07-14
B382SD1184590Surgical DirectSD118459SD1184592026-07-14
B382SD123750Surgical DirectSD12375SD123752026-07-14
B382SD123760Surgical DirectSD12376SD123762026-07-14
B382SD123780Surgical DirectSD12378SD123782026-07-14
B382SD124326191140Surgical DirectSD12432-619-114SD12432-619-1142026-07-14
B382SD12711090Surgical DirectSD1271-109SD1271-1092026-07-14
B382SD1271390Surgical DirectSD1271-39SD1271-392026-07-14
B382SD1271590Surgical DirectSD1271-59SD1271-592026-07-14
B382SD13018770Surgical DirectSD13018-77SD13018-772026-07-14
B382SD13024290Surgical DirectSD1302.429SD1302.4292026-07-14
B382SD13168350Surgical DirectSD13168-35SD13168-352026-07-14
B382SD209910FSANT0Surgical DirectSD209910-FS-AN-TSD209910-FS-AN-T2026-07-14
B382SD209920FSANT0Surgical DirectSD209920-FS-AN-TSD209920-FS-AN-T2026-07-14
B382SD209923FSANT0Surgical DirectSD209923-FS-AN-TSD209923-FS-AN-T2026-07-14
B382SD2303290Surgical DirectSD230329SD2303292026-07-14

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
B382SD92422150Surgical DirectSurgical Direct, Inc.FFS2025-03-17
B382SD512531150Surgical DirectSurgical Direct, Inc.FFS2025-03-10
00857580006829Fiber Optic Light CableGULF FIBEROPTICS, INC.FFS2025-02-26
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