FDA.reportPublic FDA data

Accessory Portal Kit, 9mm

Primary DI
00887868270000
Brand
Accessory Portal Kit, 9mm
Company
CAYENNE MEDICAL, INC.
Model
CM-7609
Catalog number
CM-7609
Published
2020-09-21
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
GEACannula, Surgical, General & Plastic Surgery
HTWBit, Drill
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEACannula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1
HTWBit, DrillOrthopedic1
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M543CM7609PreviousHIBCC0
00887868270000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868270000008878682700008878682700000887868270000

GMDN Terms#

Term, Definition table
TermDefinition
Arthroscopic surgical procedure kit, non-medicated, single-useA collection of various sterile surgical and endoscopic instruments, dressings, and additional materials intended to be used specifically to perform an arthroscopic surgical procedure. It does not contain any pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
606719685
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M543CM8010Quattro®CM-8010CM-80102019-03-29
M543CM6127BioWick SureLockCM-61272016-01-10
M543CM6255BioWick XCM-62552018-01-31
M543CM6265BioWick XCM-62652018-01-25
00887868269769BioWick® SureLock®CM-61272020-09-21
00887868269790BioWick® XCM-62552020-09-21
00887868269813BioWick® XCM-62652020-09-21
M5431100259901Ventix™1100259901100259902018-12-04
M5431100259921Ventix™1100259921100259922018-12-04
M543CM1025iFix®CM-10252015-10-09
M543CM1030iFix®CM-10302015-10-09
M543CM1130iFix®CM-11302015-10-09
M543CM1230iFix®CM-12302015-10-09
M543CM1720iFix®CM-17202015-10-09
M543CM1725iFix®CM-17252015-10-09
M543CM1820iFix®CM-18202015-10-09
M543CM1825iFix®CM-18252015-10-09
M543CM1830iFix®CM-18302015-10-09
M543CM1920iFix®CM-19202015-10-09
M543CM1925iFix®CM-19252015-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810130456574Medco ManufacturingMedco Manufacturing LLCGEA2026-07-09
00810130456581Medco ManufacturingMedco Manufacturing LLCGEA2026-07-09
00810130456598Medco ManufacturingMedco Manufacturing LLCGEA2026-07-09
00810130456604Medco ManufacturingMedco Manufacturing LLCGEA2026-07-09
00810130456611Medco ManufacturingMedco Manufacturing LLCGEA2026-07-09
00840286860093Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
00840286860109Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
00840286860116Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
10705034647463N/AMedos International SàrlLXH2026-07-09
20192253036821MonojectCardinal Health 200, LLCGEA2026-07-09
B382SD49400B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49401B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49402B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49403B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49404B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49405B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49406B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49407B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49408B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49409B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49410B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49411B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49412B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49413B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49414B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49415B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49416B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49417B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49418B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49419B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09