FDA.reportPublic FDA data

Tri-Gate Disposable Cannula

Primary DI
10818614020515
Brand
Tri-Gate Disposable Cannula
Company
Maruho Medical, Inc.
Model
00-8570
Device description
8.5 ID x 70mm Tri-Gate Disposable Cannula
Published
2022-05-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GEACannula, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEACannula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818614020515PackageGS16In Commercial Distribution
00818614020518PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081861402051510818614020515
00818614020518008186140205188186140205180818614020518

GMDN Terms#

Term, Definition table
TermDefinition
Arthroscopic access cannula, single-useA single-lumen surgical device intended to be percutaneously inserted into a joint to create an access port for an arthroscope/arthroscopic instrument during arthroscopy. The cannula is designed to facilitate the passage of surgical instruments while preventing the escape of irrigation fluid and typically includes an internal watertight seal, and a port for drainage of fluid. It is available in a variety of dimensions and/or designs and may include one or more obturator(s) to facilitate insertion. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117630237
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10818614022595Disposable Punch, 6.5 mm 00-65P2022-09-15
10818614022649ABS Med Distraction PinMDS90914142023-08-29
10818614021406Distraction Screw909-122023-01-26
10818614021413Distraction Screw909-142023-01-26
10818614022601Distraction Pin, 12MM pouchSS-0088S2022-12-19
10818614022618Distraction Pin, 14MM pouchSS-0089S 2022-12-19
10818614022571Distraction Screw, 12MM pouchSM-00882022-09-01
10818614022588Distraction Screw, 14MM pouchSM-00892022-09-01
10818614020492Tri-Gate Disposable Cannula00-65702022-05-10
10818614020508Tri-Gate Disposable Cannula00-75702022-05-10
10818614020522Tri-Gate Disposable Cannula00-65902022-05-10
10818614020539Tri-Gate Disposable Cannula00-75902022-05-10
10818614020546Tri-Gate Disposable Cannula00-85902022-05-10
10818614021215Tri-Gate Notched Disposable Cannula00-857002022-05-10
10818614022489Galen Small Joint AnchorF-08-111062022-05-10
10818614022496Galen Small Joint AnchorF-08-111082022-05-10
10818614022526Kopis Knotless AnchorF-31-145202022-05-10
10818614022533Kopis Knotless AnchorF-31-155202022-05-10
10818614022540Kopis Knotless AnchorF-31-165202022-05-10
20818614022509Distraction Pin , 12MM Pouch909-12909-12-K2022-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810130456789Medco ManufacturingMedco Manufacturing LLCGEA2026-08-25
00810130456796Medco ManufacturingMedco Manufacturing LLCGEA2026-08-25
00810130456819Medco ManufacturingMedco Manufacturing LLCGEA2026-08-25
00190776419066MillenniumAvalign Technologies, Inc.GEA2026-08-23
00190776419639MillenniumAvalign Technologies, Inc.GEA2026-08-23
00850012846741JNW URTRACLSI Solutions, Inc.GEA2026-08-21
00884450681329Preston™Merit Medical Systems, Inc.GEA2026-08-21
00884450681336Preston™Merit Medical Systems, Inc.GEA2026-08-21
00884450681343Preston™Merit Medical Systems, Inc.GEA2026-08-21
00884450681350Preston™Merit Medical Systems, Inc.GEA2026-08-21
04054462902583evonosevonos GmbH & Co. KGGEA2026-08-21
04054462902590evonosevonos GmbH & Co. KGGEA2026-08-21
04054462902606evonosevonos GmbH & Co. KGGEA2026-08-21
04054462902613evonosevonos GmbH & Co. KGGEA2026-08-21
04054462902620evonosevonos GmbH & Co. KGGEA2026-08-21
04054462902637evonosevonos GmbH & Co. KGGEA2026-08-21
04054462902644evonosevonos GmbH & Co. KGGEA2026-08-21
04054462902651evonosevonos GmbH & Co. KGGEA2026-08-21
04054462902668evonosevonos GmbH & Co. KGGEA2026-08-21
00190776417062MillenniumAvalign Technologies, Inc.GEA2026-08-18
00190776407506MillenniumAvalign Technologies, Inc.GEA2026-07-31
00840329838409BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GEA2026-07-30
00840329838416BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GEA2026-07-30
00840329838430BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GEA2026-07-30
00840329838454BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GEA2026-07-30
00840329838515BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GEA2026-07-30
00810130456710Medco ManufacturingMedco Manufacturing LLCGEA2026-07-23
00810130456727Medco ManufacturingMedco Manufacturing LLCGEA2026-07-23
00810130456734Medco ManufacturingMedco Manufacturing LLCGEA2026-07-23
00810130456741Medco ManufacturingMedco Manufacturing LLCGEA2026-07-23