FDA.reportPublic FDA data

RebarTM

Primary DI
00847536026858
Brand
RebarTM
Company
Micro Therapeutics, Inc.
Model
105-5083-153
Device description
MICRO CATH 105-5083-153 V01 REBAR
Published
2017-09-17
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
K001966000
K093750000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001966000REBAR MICRO CATHETER: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, SINGLE MARKER BAND AND 153 CM, DUAL MARKER BANDMicro Therapeutics, Inc.2000-07-20KRA
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
00847536026858PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847536026858008475360268588475360268580847536026858

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA sterile, flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section of the tube can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended for infusion, is not a microcatheter (i.e., not intended to access superselective small vessels), and does not include a transseptal needle. It may include a disposable percutaneous introduction set. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature50 Degrees Fahrenheit90 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

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

Regulatory Flags#

DUNS number
826110710
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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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
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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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