FDA.report

N/A

Primary DI
00763000343231
Brand
N/A
Company
MEDTRONIC PS MEDICAL, INC.
Model
46422
Device description
ASSEMBLY 46422 EDM DRAINAGE
Published
2020-04-20
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

Contact Domains

Product Codes

CodeName
GWMDevice, monitoring, intracranial pressure

Product Code Classifications

CodeDeviceSpecialtyClass
GWMDevice, Monitoring, Intracranial PressureNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00763000343231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000343231007630003432317630003432310763000343231

GMDN Terms

TermDefinition
Cerebrospinal fluid external drainage kitA collection of sterile devices intended to be used with an intracerebral or spinal infusion/drainage catheter (not included) to collect drained cerebrospinal fluid (CSF), and other fluids of similar physical characteristics, from the brain ventricles or from the lumbar subarachnoid (intrathecal) region as a means of reducing CSF volume and intracranial pressure (ICP). It typically includes devices such as a drip chamber, drainage bag, tubing set, catheter connector, stopcock, and filter. This is a single-use device.

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
089055867
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00763000422646StrataMR246955MR2026-03-13
00763000422684StrataMR246957MR2026-03-13
00763000422660StrataMR II46956MR2025-05-02
00763000950941Duet EDMS469132025-03-23
00763000950972Duet EDMS469142025-03-23
00763000281243Exacta Pole Clamp with laser level467152025-02-17
00763000281229Exacta Pole Clamp with laser level467112025-02-16
00763000413255Exacta™467112020-11-19
00763000413262Exacta™467152020-11-19
00763000422653Valve, StrataMR II, Regular46965MR2025-01-23
00763000422677Snap Shunt Assembly, StrataMR II, Regular46966MR2025-01-23
00763000422691Unassembled Shunt Kit, StrataMR II, Regular46967MR2025-01-23
00763000422738StrataMR II46965MR2022-12-24
00763000422752StrataMR II46966MR2022-12-24
00763000422776StrataMR II46967MR2022-12-24
00763000333461Exacta™275792020-06-08
00763000333478Exacta™275812020-06-08
00763000333492Exacta™276362020-06-08
00763000333508Exacta™276542020-06-08
00763000333515Exacta™276662020-06-08

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04057834023541Tunneling KIT CH8RAUMEDIC AGGWM2025-12-08
04057834090468Tunneling KIT CH12RAUMEDIC AGGWM2025-12-08
04057834026115NEUROVENT-PRAUMEDIC AGGWM2025-12-05
04057834082845NEUROVENTRAUMEDIC AGGWM2025-12-05
04057834082876NEUROVENT-IFD-SRAUMEDIC AGGWM2025-12-05
04057834082883NEUROVENT-IFD-RRAUMEDIC AGGWM2025-12-05
04057834082906NEUROVENT-TEMP-IFD-SRAUMEDIC AGGWM2025-12-05
04057834082913NEUROVENT-TEMP-IFD-RRAUMEDIC AGGWM2025-12-05
04057834082920NEUROVENT-P-TEMPRAUMEDIC AGGWM2025-12-05
04057834082937NEUROVENT-TEMPRAUMEDIC AGGWM2025-12-05
04057834082968NEUROVENT-PTORAUMEDIC AGGWM2025-12-05
04057834083026NEUROVENT-PTO 2LRAUMEDIC AGGWM2025-12-05
04057834088410NEUROVENT-PXRAUMEDIC AGGWM2025-12-05
04057834097559BOLT-DRILL KIT CH5RAUMEDIC AGGWM2025-12-05
04057834097566BOLT-DRILL KIT CH9RAUMEDIC AGGWM2025-12-05
04057834097610BOLT-DRILL KIT PTORAUMEDIC AGGWM2025-12-05
10850013266279IRRAflow Cranial Access BoltIrras USA, Inc.GWM2025-07-24
00763000950941Duet EDMSMEDTRONIC PS MEDICAL, INC.GWM2025-03-23
00763000950972Duet EDMSMEDTRONIC PS MEDICAL, INC.GWM2025-03-23
10381780544319Codman® CereLink®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGWM2025-03-12
07908398200268BraincareBRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA SAGWM2024-08-28
07908398200275BraincareBRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA SAGWM2024-08-28
07908398200282BraincareBRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA SAGWM2024-08-28
07908398200299BraincareBRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA SAGWM2024-08-28
00382830048835NatusNATUS MEDICAL INCORPORATEDGWM2024-07-10
00382830048842NatusNATUS MEDICAL INCORPORATEDGWM2024-07-10
00382830059701NatusNATUS MEDICAL INCORPORATEDGWM2024-07-10
00382830059718NatusNATUS MEDICAL INCORPORATEDGWM2024-07-10
00382830059725NatusNATUS MEDICAL INCORPORATEDGWM2024-07-10
00382830059732NatusNATUS MEDICAL INCORPORATEDGWM2024-07-10