FDA.report

NA

Primary DI
00681490143653
Brand
NA
Company
MEDTRONIC, INC.
Model
6211-S1
Device description
INTRO 6211-S1 ACCESSORY 11F
Published
2017-01-03
Public version status
Update
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

Product Codes

CodeName
DYBINTRODUCER, CATHETER

Product Code Classifications

CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions

SubmissionSupplement
K911236000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K911236000MEDTRONIC PERMANENT LEAD INTRODUCER, VARIOUS MDLSMedtronic Vascular1991-06-18DYB

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00681490143653PrimaryGS10

GMDN Terms

TermDefinition
Vascular catheter introduction set, nonimplantableA collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit104 Degrees Fahrenheit

Sterilization Methods

Method

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
true
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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