FDA.reportPublic FDA data

Gyrus ACMI

Primary DI
00821925038103
Brand
Gyrus ACMI
Company
Gyrus ACMI, LLC
Model
ACN-BP
Device description
Biopsy Port Seal (6/PK)
Published
2016-10-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FAJCystoscope and accessories, flexible/rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FAJCystoscope And Accessories, Flexible/RigidGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012929000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012929000FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735Circon Video2001-11-19FAJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925008816PackageGS16Not in Commercial Distribution
00821925038103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925008816008219250088168219250088160821925008816
00821925038103008219250381038219250381030821925038103

GMDN Terms#

Term, Definition table
TermDefinition
Rigid optical cystoscopeAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the bladder and the urinary tract. It is inserted into the urethra (the tube that carries urine from the bladder to the outside of the body) through the natural urinary orifice during cystoscopy. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. It is used to examine/diagnose incontinence, the inability to pass urine (retention), recurrent urinary tract infections, to remove tissue samples/stones/small tumours from the bladder, and for removal of the prostate. This is a reusable device.

Regulatory Flags#

DUNS number
007198742
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00821925034013Expandacell708907302018-09-13
00821925034020Gyrus ACMI708909072018-09-13
00821925034037Gyrus ACMI708909082018-09-13
00821925034532Gyrus ACMI8909112018-09-13
00821925037069Rhino Rocket708907292018-09-13
00821925037076Rhino Rocket708907312018-09-13
00821925037090Gyrus ACMI708907332018-09-13
00821925037106SlimLine708907342018-09-13
00821925037113Gyrus ACMI708907352018-09-13
00821925037120Gyrus ACMI708907372018-09-13
00821925037137Gyrus ACMI708907382018-09-13
00821925037144Gyrus ACMI708907392018-09-13
00821925037151Gyrus ACMI708907402018-09-13
00821925037168Gyrus ACMI708907412018-09-13
00821925037175Gyrus ACMI708907422018-09-13
00821925037182Gyrus ACMI708907432018-09-13
00821925037199Gyrus ACMI708907502018-09-13
00821925037205Gyrus ACMI708907512018-09-13
00821925037212Gyrus ACMI708907522018-09-13
00821925037229Gyrus ACMI708907532018-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840432200001CFlex™Verathon Medical (Canada) ULCFAJ2026-05-15
00840432200018CFlex™Verathon Medical (Canada) ULCFAJ2026-05-15
00810116023424Dornier MedTechDORNIER MEDTECH AMERICA, INC.FAJ2026-05-06
00850023925381AptraOtu Medical Inc.FAJ2024-09-30
00850023925398AptraOtu Medical Inc.FAJ2024-09-30
00850023925428WiScope®Otu Medical Inc.FAJ2024-09-30
00850023925435WiScope®Otu Medical Inc.FAJ2024-09-30
04055207038512RIWORichard Wolf GmbHFAJ2024-08-19
04055207008607NARichard Wolf GmbHFAJ2024-08-19
00677964074936ENDO SMARTCAPMEDIVATORS INC.FAJ2024-05-29
07613327616675SPYSTRYKER CORPORATIONFAJ2024-02-27
07613327616736SPYSTRYKER CORPORATIONFAJ2024-02-27
10818634025149AmbuBosma EnterprisesFAJ2023-05-01
10818634025194AmbuBosma EnterprisesFAJ2023-05-01
50724995219241ENDO SMARTCAPMEDIVATORS INC.FAJ2023-04-28
50724995219258ENDO SMARTCAPMEDIVATORS INC.FAJ2023-04-28
50724995219265ENDO SMARTCAPMEDIVATORS INC.FAJ2023-04-28
50724995219272ENDO SMARTCAPMEDIVATORS INC.FAJ2023-04-28
00848657076135AED Flexible Cystoscopy Biopsy Forcep, 1.8mm x 65cmNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2023-01-25
00848657076142AED Flexible Cystoscopy Alligator Forcep S/A, 1.8mm x 65cmNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2023-01-25
00848657076159AED Flexible Cystoscopy Alligator Forcep D/A, 1.8mm x 65cmNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2023-01-25
00848657076166AED Flexible Cystoscopy Rat Tooth Forcep, 1.8mm x 65cmNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2023-01-25
00860008483706Uro-G Flexible CystoscopeUROVIU CORP.FAJ2022-12-16
00850006759668Aveta Auto 5 Fr Disposable Resecting DeviceMEDITRINA, INC.FAJ2022-08-18
00850023925169WiScope®Otu Medical Inc.FAJ2022-04-18
00850023925176WiScope®Otu Medical Inc.FAJ2022-04-18
00850023925183WiScope®Otu Medical Inc.FAJ2022-04-18
00850023925190WiScope®Otu Medical Inc.FAJ2022-04-18
00853277008084LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)UVISION 360, INC.FAJ2021-08-13
00853277008091LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)UVISION 360, INC.FAJ2021-08-13