FDA.report

N/A

Primary DI
00763000343224
Brand
N/A
Company
MEDTRONIC PS MEDICAL, INC.
Model
46141
Device description
KIT 46141 EDM VEN 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
GWNNYSTAGMOGRAPH

Product Code Classifications

CodeDeviceSpecialtyClass
GWNNystagmographNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20763000343228PrimaryGS10
00763000343224Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2076300034322820763000343228
00763000343224007630003432247630003432240763000343224

GMDN Terms

TermDefinition
Ventricular cerebrospinal fluid drainage catheterization kitA collection of sterile devices intended for short-term access to the brain ventricles 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 an intracerebral infusion/drainage catheter and devices intended for catheter insertion (e.g. stylet) and CSF collection (e.g., drip chamber, drainage bag, tubing set). 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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