FDA.reportPublic FDA data

Rebar

Primary DI
00836462002081
Brand
Rebar
Company
Micro Therapeutics, Inc.
Model
105-5078-153
Device description
10 Micro Catheter
Published
2015-10-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KRACatheter, continuous flush

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRACatheter, Continuous FlushCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093750000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093750000ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, REBAEv3, Inc.2009-12-09KRA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00836462002081PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00836462002081008364620020818364620020810836462002081

GMDN Terms#

Term, Definition table
TermDefinition
Vascular microcatheterA sterile, small-diameter, single-lumen, flexible tube designed for the controlled infusion of fluids (e.g., thrombolytics, diagnostic contrast media) into superselective small vessels (including intracranial, peripheral, or occluded coronary vasculature) for angiography/treatment, and typically also for the delivery of devices (e.g., embolization implants, guidewires) into tortuous vessels or across tight lesions. It may include an ultrasound transducer, a thermal sensor, and a hole for guidewire placement located at the distal tip. It is not a guide-catheter (i.e., is not intended to deliver other catheters or therapeutic leads directly through its lumen). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length153Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry;Avoid extreme temperatures
Special Storage Condition, Specify00Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Storage Environment Temperature50 Degrees Fahrenheit90 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com
+1(800)633-8766covidien.udi@covidien.com
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
826110710
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

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00847536036413PipelineTM Vantage Embolization Device with Shield TechnologyTMPED3-021-325-102023-12-31
00847536036475PipelineTM Vantage Embolization Device with Shield TechnologyTMPED3-021-325-252023-12-31
00763000495619Axium™ Prime Detachable Coil SystemFC-8-30-3D2023-08-07
00763000495640Axium™ Prime Detachable Coil SystemFC-10-20-3D2023-08-07
00763000488673Axium™ Detachable Coil SystemQC-14-40-3D2022-10-28
00763000488703Axium™ Detachable Coil SystemQC-20-50-3D2022-10-28
00763000488734Axium™ Detachable Coil SystemNC-2-1-HELIX2022-10-28
00763000488949Axium™ Detachable Coil SystemPC-4-10-HELIX2022-10-28
00763000489182Axium™ Detachable Coil SystemPC-5-10-3D2022-10-28
00763000489250Axium™ Detachable Coil SystemPC-7-30-3D2022-10-28
00763000489281Axium™ Detachable Coil SystemPC-8-30-3D2022-10-28
00763000489328Axium™ Detachable Coil SystemPC-10-30-3D2022-10-28
00763000425272Solitaire ™ PlatinumSFR3-4-20-102021-03-12
00763000425333Solitaire ™ PlatinumSFR3-4-40-102021-03-12
00763000425395Solitaire ™ PlatinumSFR3-6-20-102021-03-12
00763000425456Solitaire ™ PlatinumSFR3-4-20-052021-03-12
00836462018273N/ANCS-2.75-52016-10-02
00763000270704Solitaire™ X-PACKXPACK3362019-11-08
00763000270766Solitaire™ X-PACKXPACK3422019-11-08

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