FDA.report

Tubing Set

Primary DI
00763000956028
Company
MEDTRONIC XOMED, INC.
Model
3318604E
Device description
IRRIG SET 3318604E IPC SUCTION W/RC
Published
2026-02-14
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

Related Records

Regulatory Flags

DUNS number
835465063
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Identifiers

IdentifierTypeAgencyPackage quantityStatus
00763000956028PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
00763000956028PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
HRXArthroscope2Orthopedic888.1100NIneligible

Premarket Submissions

SubmissionSupplement
K081475000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K081475000ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)]Medtronic Xomed, Inc.2008-10-17HBE

GMDN Terms

TermDefinition
Surgical irrigation tubing set, single-useA collection of flexible, noninvasive, single-lumen tubing and associated items intended to provide a conduit to deliver a sterile irrigation solution (e.g., saline) from its source (e.g., gravity feed bag, feed pump) to a surgical cannula (not included) during a surgical procedure (endoscopy, laparoscopy); it is not intended to navigate through an anatomical lumen. The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Other Devices From This Company

Primary DIBrandModelCatalogPublished
20763000888989Merocel4005152026-03-08
20763000888996Merocel4404122026-03-08
00763000892951M41898200T2026-02-28
00199150023851N/A8225101E2026-02-16
00199150023868N/A82251012026-02-16
00199150023875N/A82251102026-02-16
00199150023882N/A82251032026-02-16
00763000548797Hydrodebrider19140012026-02-14
00763000548803Hydrodebrider19210022026-02-14
20763000888910Merocel4001512026-02-15
20763000888927Merocel4001522026-02-15
00763000945671ApexCut187BL40002026-02-05
00763000945725ApexCut187BL40122026-02-05
00763000945749ApexCut187BL40402026-02-05
00643169547087NIM®82534022025-09-13
00763000745080NuVent™18INFKIT2025-08-15
00763000831479NIM™NIMDTP352025-08-11
20763000831480NIM™8225490X2025-08-11
20763000831497NIM™8225825X2025-08-11
00763000309480Causse/Polycel11563762025-06-23

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10845854041116POWERPROConmed CorporationHRX2026-03-24
04056702011970PUREVUE™ FMSW.O.M. World of Medicine GmbHHRX2026-03-10
04056702011987Autoclavable remote controlW.O.M. World of Medicine GmbHHRX2026-03-10
04056702011994Double pedal foot switchW.O.M. World of Medicine GmbHHRX2026-03-10
04056702012014Tube set for irrigation, single-useW.O.M. World of Medicine GmbHHRX2026-03-10
04056702012038Tube set for suction, 2-lines, single-useW.O.M. World of Medicine GmbHHRX2026-03-10
04056702012052Day use tube set for irrigation, pump part, 10 applicationsW.O.M. World of Medicine GmbHHRX2026-03-10
04056702012076Patient tube for irrigation, single-useW.O.M. World of Medicine GmbHHRX2026-03-10
04056702012090Tube set for vacuum, incl. filter, 30-day useW.O.M. World of Medicine GmbHHRX2026-03-10
04056702012113Tube set for suction, single-useW.O.M. World of Medicine GmbHHRX2026-03-10
04056702012137Tube set inflow 4-Spike adaptorW.O.M. World of Medicine GmbHHRX2026-03-10
B382SD401290Surgical DirectSurgical Direct, Inc.HRX2026-02-09
B382SD401490Surgical DirectSurgical Direct, Inc.HRX2026-02-09
08031497003689Mendec® Kypho Set Monolateral 10 mmTECRES SPAHRX2025-12-17
08031497003696Mendec® Kypho Set Monolateral 15 mmTECRES SPAHRX2025-12-17
08031497003702Mendec® Kypho Set Monolateral 20 mmTECRES SPAHRX2025-12-17
08031497003801Mendec® Kypho Set Bilateral 10 mmTECRES SPAHRX2025-12-17
08031497003818Mendec® Kypho Set Bilateral 15 mmTECRES SPAHRX2025-12-17
08031497003825Mendec® Kypho Set Bilateral 20 mmTECRES SPAHRX2025-12-17
06938695521026DrillShanghai Kinetic Medical Co., Ltd.HRX2025-12-09
08800038029323SteriSpine VA IMEDICOM CO., LTD.HRX2025-09-24
08800038029330SteriSpine VA IMEDICOM CO., LTD.HRX2025-09-24
08800038029347SteriSpine VA IMEDICOM CO., LTD.HRX2025-09-24
08800038029354SteriSpine VA IMEDICOM CO., LTD.HRX2025-09-24
08800038029361SteriSpine VA IMEDICOM CO., LTD.HRX2025-09-24
08800038029378SteriSpine VA IMEDICOM CO., LTD.HRX2025-09-24
08800038029415SteriSpine VA IMEDICOM CO., LTD.HRX2025-09-24
08800038029422SteriSpine VA IMEDICOM CO., LTD.HRX2025-09-24
08800038039407SteriSpine VA IMEDICOM CO., LTD.HRX2025-09-24
08800038039414SteriSpine VA IMEDICOM CO., LTD.HRX2025-09-24