FDA.reportPublic FDA data

Gyrus ACMI

Primary DI
00821925005204
Brand
Gyrus ACMI
Company
Gyrus ACMI, LLC
Model
437A
Device description
Straight Lowsley Tractor Single-Action, Stem Only 21.5 Fr (7.1 mm) With 8 Inch (203 mm) Working Length
Published
2016-10-12
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
KOBCATHETER, SUPRAPUBIC (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOBCatheter, Suprapubic (And Accessories)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012153000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012153000LOWSLEY SUPRAPUBIC TRACTORCircon Video2001-09-19KOB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925005204PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925005204008219250052048219250052040821925005204

GMDN Terms#

Term, Definition table
TermDefinition
Gastro-urological hookA hand-held, shaft-like, manual surgical instrument designed to fix or apply traction to various anatomical structures in gastro-urological (GU) surgical procedures. The device tapers towards the distal end to form a hook or multiple hooks used in the procedure. The proximal end forms a handle which may vary in shape. In multiple hook designs, the hooks are in parallel. 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
00821925014206Gyrus ACMI1404202015-10-24
00821925014213Gyrus ACMI1404212015-10-24
00821925014237Gyrus ACMI1404232015-10-24
00821925014244Gyrus ACMI1404252015-10-24
00821925014251Gyrus ACMI1404262015-10-24
00821925014268Gyrus ACMI1404272015-10-24
00821925014299Gyrus ACMI1404342015-10-24
00821925014558Gyrus ACMI1403402015-10-24
00821925014565Gyrus ACMI1403412015-10-24
00821925014572Gyrus ACMI1404102015-10-24
00821925014589Gyrus ACMI1404112015-10-24
00821925014596Gyrus ACMI1404122015-10-24
00821925014619Gyrus ACMI1404152015-10-24
00821925014626Gyrus ACMI1404162015-10-24
00821925014640Gyrus ACMI1404182015-10-24
00821925014916Gyrus ACMI1403302015-10-24
00821925015210Gyrus ACMI1403312015-10-24
00821925015227Gyrus ACMI1403322015-10-24
00821925015234Gyrus ACMI1403332015-10-24
00821925015241Gyrus ACMI1403342015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842071153045AMT MiniSPC Drainage SetAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-04-28
00842071153069AMT MiniSPC Drainage SetAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-04-28
00842071150952AMT MiniSPC Drainage SetAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071150976AMT MiniSPC Drainage SetAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152758MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152765MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152772MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152789MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152796MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152802MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152819MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152826MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152833MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152840MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152857MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152864MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152871MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152888MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152895MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152901MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152918MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152925MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071149932MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-16
00842071149949MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-16
00842071149956MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-16
00842071149963MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-16
00842071149970MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-16
00842071149987MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-16
00842071149994MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-16
00842071150006MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-16