FDA.reportPublic FDA data

Gyrus ACMI

Primary DI
00821925008809
Brand
Gyrus ACMI
Company
Gyrus ACMI, LLC
Model
98-0759
Device description
Light Guide Adapter, M3 Gold (Wolf)
Published
2018-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K911053000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K911053000CIRCON ACMI HYDROLAPAROSCOPE(TM) INSTRUMENTCircon Video1991-06-03GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925008809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925008809008219250088098219250088090821925008809

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic light source adaptorA device that provides an optical interface to match the light characteristics from an external light source (from a different endoscope manufacturer or model) to the fibreoptic bundles of an endoscope. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
007198742
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00821925033900DIEGO701390022024-07-25
00821925033917DIEGO701390062024-07-24
00821925034419DIEGO701390332024-07-23
00821925034730Gyrus ACMI703531002017-05-11
00821925034754Gyrus ACMI703531122017-05-11
00821925035935OLYMPUS37402016-10-03
00821925001428GYRUS ACMICW-USLPC2016-10-13
00821925035874OLYMPUS30002016-09-30
00821925035911Gyrus ACMI34002016-10-12
00821925041547Gyrus ACMI30252016-09-30
00821925010567Gyrus ACMI39992024-07-24
00821925002746Gyrus ACMIENDO-ST2016-10-14
00821925011410DIEGO703390012016-10-12
00821925011441DIEGO703380002017-05-11
00821925021594SMART701421682015-10-24
00821925021617VOCOM701430192015-10-24
00821925026179Diego703380122016-10-06
00821925028746Diego703390002016-10-06
00821925034174Gyrus ACMI701410322015-10-24
00821925035898OLYMPUS30062016-09-30

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
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