FDA.reportPublic FDA data

Gyrus ACMI

Primary DI
00821925038066
Brand
Gyrus ACMI
Company
Gyrus ACMI, LLC
Model
608BX
Device description
10FR (3.3mm) DUAL LUMEN CATHETER
Published
2024-07-25
Public version status
Update
Distribution status
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
EYBCatheter, Ureteral, Gastro-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EYBCatheter, Ureteral, Gastro-UrologyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K043581000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K043581000DUAL LUMEN CATHETERAcmi Corporation2005-03-03EYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925010932PackageGS15In Commercial Distribution
00821925038066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925010932008219250109328219250109320821925010932
00821925038066008219250380668219250380660821925038066

GMDN Terms#

Term, Definition table
TermDefinition
Ureteral catheterA flexible tube designed for introduction into the ureters through a cystoscope, ureteroscope or nephroscope. It is typically a 3 to 12 Fr radiopaque tube with one of several tip configurations (e.g., straight, bent, olive). It may have a single or double-lumen and graduated markings. The device is used for ureter dilation, bypass of partial obstructions, urinary tract irrigation/drainage during surgery (e.g., injection of contrast agent, anaesthetic agent and/or antiretropulsion gel), stone removal, retrograde urography, guidewire placement, and/or brush biopsy. This is a single-use device.

Regulatory Flags#

DUNS number
007198742
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
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

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Primary DI, Brand, Company table
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03600040964163ColoplastColoplast A/SEYB2026-01-30
03600040964224ColoplastColoplast A/SEYB2026-01-30
03600040964286ColoplastColoplast A/SEYB2026-01-30
03600040964347ColoplastColoplast A/SEYB2026-01-30
03600040964408ColoplastColoplast A/SEYB2026-01-30
03600040964644ColoplastColoplast A/SEYB2026-01-30
03600040965870ColoplastColoplast A/SEYB2026-01-30
03600040965931ColoplastColoplast A/SEYB2026-01-30
03600040965993ColoplastColoplast A/SEYB2026-01-30
03600040966051ColoplastColoplast A/SEYB2026-01-30
03600040966112ColoplastColoplast A/SEYB2026-01-30
03600040966204ColoplastColoplast A/SEYB2026-01-30
03600040966297ColoplastColoplast A/SEYB2026-01-30
03600040966389ColoplastColoplast A/SEYB2026-01-30
03600040966471ColoplastColoplast A/SEYB2026-01-30
03600040966532ColoplastColoplast A/SEYB2026-01-30
03600040966594ColoplastColoplast A/SEYB2026-01-30
03600040966655ColoplastColoplast A/SEYB2026-01-30
03600040966716ColoplastColoplast A/SEYB2026-01-30
03600040966778ColoplastColoplast A/SEYB2026-01-30
03600040966839ColoplastColoplast A/SEYB2026-01-30
03600040966891ColoplastColoplast A/SEYB2026-01-30
03600040966983ColoplastColoplast A/SEYB2026-01-30
03600040967041ColoplastColoplast A/SEYB2026-01-30
03600040967133ColoplastColoplast A/SEYB2026-01-30
03600040967195ColoplastColoplast A/SEYB2026-01-30