FDA.report

N/A

Primary DI
00763000343255
Brand
N/A
Company
MEDTRONIC PS MEDICAL, INC.
Model
46441
Device description
KIT 46441 EDM LUMBAR DRAINAGE 5PK
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
20763000343259PrimaryGS10
00763000343255Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2076300034325920763000343259
00763000343255007630003432557630003432550763000343255

GMDN Terms

TermDefinition
Lumbar cerebrospinal fluid drainage catheterization kitA collection of sterile devices intended for short-term percutaneous access to the subarachnoid (intrathecal) or epidural space of the lumbar spinal column to drain cerebrospinal fluid (CSF), and/or other fluids of similar physical characteristics, as a means of reducing CSF volume and intracranial pressure (ICP). It includes a spinal infusion/drainage catheter and devices intended for catheter insertion (e.g. Tuohy needle, suture, guidewire) and CSF collection (e.g., drip chamber, drainage bag, tubing set, 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
5
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

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