FDA.report

NA

Primary DI
00721902035166
Brand
NA
Company
MEDTRONIC, INC.
Model
5410S
Device description
CABLE 5410S SURGICAL BIP PKGD 10L
Published
2016-04-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Product Code Classifications

CodeDeviceSpecialtyClass
DRFCatheter, Electrode Recording, Or Probe, Electrode RecordingCardiovascular2

Premarket Submissions

SubmissionSupplement
K914460000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K914460000MEDTRONIC MODEL 5407S, 5807S & 5410S SURG CABLESMedtronic Vascular1991-11-22DRF

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00721902035166PrimaryGS10

GMDN Terms

TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature-40 Degrees Celsius65 Degrees Celsius

Sterilization Methods

Method
Ethylene Oxide;Moist Heat or Steam Sterilization

Contacts

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

Regulatory Flags

DUNS number
006261481
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
true

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