FDA.reportPublic FDA data

EDM

Primary DI
00643169497603
Brand
EDM
Company
MEDTRONIC PS MEDICAL, INC.
Model
46135
Device description
CLAMP 46135 QUICK ATTACH POLE
Published
2017-08-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWMDEVICE, MONITORING, INTRACRANIAL PRESSURE
JXGShunt, central nervous system and components

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWMDevice, Monitoring, Intracranial PressureNeurology2
JXGShunt, Central Nervous System And ComponentsNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K983799000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K983799000MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM, MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM POLE CLAMP, MEDTRONIC PS MEDICLMedtronic PS Medical1999-01-26GWM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169497603PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169497603006431694976036431694976030643169497603

GMDN Terms#

Term, Definition table
TermDefinition
Medical device service rail clampA clamp designed to fit onto a medical device mounting rail or medical device service rail system to provide a secure method of fixing/mounting (holding) other medical or non-medical devices being used in the vicinity for patient treatment/care. It will typically be used in a hospital ward, a treatment room or an intensive care unit (ICU). It will have a gripping profile that is compatible to the medical rail it is intended to fit and a locking mechanism providing extra safety against inadvertent loosening. To this clamp, other adaptors may be fitted/slotted to provide holders for the devices to be carried, or it may have a dedicated function for which it is solely designed.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length2.98Inch

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
No natural rubber latex
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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10381780534020CODMAN® HAKIM®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2023-07-13
10381780534037CODMAN® HAKIM®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2023-07-13
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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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