FDA.reportPublic FDA data

Duet®

Primary DI
00613994445407
Brand
Duet®
Company
MEDTRONIC PS MEDICAL, INC.
Model
46917
Device description
EDMS 46917 DUET INTERLINK WITH LCATH
Published
2015-07-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWMDEVICE, MONITORING, INTRACRANIAL PRESSURE
JXGShunt, central nervous system and components
PCBExternal cerebrospinal fluid (CSF) diversion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWMDevice, Monitoring, Intracranial PressureNeurology2
JXGShunt, Central Nervous System And ComponentsNeurology2
PCBExternal Cerebrospinal Fluid (Csf) DiversionNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K984053000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K984053000BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEMMedtronic PS Medical1999-02-04JXG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994445407PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994445407006139944454076139944454070613994445407

GMDN Terms#

Term, Definition table
TermDefinition
Lumbar cerebrospinal fluid drainage kitA sterile collection of items designed for use with dimensionally compatible devices for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics from the lumbar subarachnoid (intrathecal) region as a means of reducing intracranial pressure (ICP) and CSF volume. It typically includes a catheter, a Tuohy needle, suture, and connectors. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
089055867
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000029449N/A8023 B2020-03-07
00763000030827N/A250772020-03-08
00643169483316NA8023 B2015-06-24
00643169498365NA250772015-07-14
00643169507517NA8023 A2015-06-25
00643169073623NA250772015-06-25
00643169466142N/A461412015-07-15
00673978228969NA464222015-06-18
00673978246017NA272972015-07-21
00673978246031NA273022015-07-14
20643169466122N/A464402015-07-15
00763000422646StrataMR246955MR2026-03-13
00763000422684StrataMR246957MR2026-03-13
00673978226835NA8591-602015-11-25
00643169497955Clear-Site®469182015-09-16
00613994450661Clear-Site®469182015-07-16
00763000422660StrataMR II46956MR2025-05-02
00763000422653Valve, StrataMR II, Regular46965MR2025-01-23
00763000422677Snap Shunt Assembly, StrataMR II, Regular46966MR2025-01-23
00763000422691Unassembled Shunt Kit, StrataMR II, Regular46967MR2025-01-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07908398200008BraincareBRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA SAGWM2026-05-08
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10381780534013CODMAN® HAKIM®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2023-07-13
10381780534020CODMAN® HAKIM®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2023-07-13
10381780534037CODMAN® HAKIM®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2023-07-13
10381780534044CODMAN® HAKIM®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2023-07-13
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10381780534204CODMAN® HAKIM®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2022-11-14
10381780534211CODMAN® HAKIM®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2022-11-14
10381780534228CODMAN® HAKIM®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2022-11-14
10381780534235CODMAN® HAKIM®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2022-11-14
10381780534242CODMAN® HAKIM®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2022-11-14
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