FDA.reportPublic FDA data

RebarTM

Primary DI
00847536026896
Brand
RebarTM
Company
Micro Therapeutics, Inc.
Model
105-5082-145
Device description
MICRO CATH 105-5082-145 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
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
00847536026896PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847536026896008475360268968475360268960847536026896

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

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
00763000270179Solitaire™ X-PACKXPACK2012019-11-08
00763000270193Solitaire™ X-PACKXPACK2032019-11-08
00763000270353Solitaire™ X-PACKXPACK3012019-11-08
00763000270377Solitaire™ X-PACKXPACK3032019-11-08
00763000270537Solitaire™ X-PACKXPACK3192019-11-08
00763000270551Solitaire™ X-PACKXPACK3212019-11-08
00763000270216Solitaire™ X-PACKXPACK2052019-11-07
00763000270230Solitaire™ X-PACKXPACK2072019-11-07
00763000270254Solitaire™ X-PACKXPACK2092019-11-07
00763000270292Solitaire™ X-PACKXPACK2132019-11-07
00763000270315Solitaire™ X-PACKXPACK2152019-11-07
00763000270339Solitaire™ X-PACKXPACK2172019-11-07
00763000270391Solitaire™ X-PACKXPACK3052019-11-07
00763000270414Solitaire™ X-PACKXPACK3072019-11-07
00763000270438Solitaire™ X-PACKXPACK3092019-11-07
00763000270476Solitaire™ X-PACKXPACK3132019-11-07
00763000270490Solitaire™ X-PACKXPACK3152019-11-07
00763000270513Solitaire™ X-PACKXPACK3172019-11-07
00763000270582Solitaire™ X-PACKXPACK3242019-11-07
00763000270605Solitaire™ X-PACKXPACK3262019-11-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00191506067342TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
00191506067359TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
00191506067366TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
00191506067373TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
00191506067380TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
00191506067397TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
00191506067403TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
00191506067410TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
00885403522348SWAN-GANZ CCOMBO VBecton, Dickinson And CompanyKRA2026-05-30
00885403523819VAMPBecton, Dickinson And CompanyKRA2026-05-30
00884450826492Fountain®Merit Medical Systems, Inc.KRA2026-05-29
00860011713135FLOWRUNNER 7F Aspiration System, 130cmExpanse Medical, Inc.KRA2026-05-28
00860011713159FLOWRUNNER SP 7F Aspiration System, 130cmExpanse Medical, Inc.KRA2026-05-28
G4533352797GM8M50PEAK MEDICALPeak Medical Distribution Inc.KRA2026-05-27
15051684023801Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023825Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023832Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023849Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023856Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023863Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023870Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023887Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023894Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023900Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023924Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023931Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023948Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023955Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
07640132622690M-CATH Flexy Acrostak (Schweiz) AGKRA2021-11-01
07640132622706M-CATH Flexy Acrostak (Schweiz) AGKRA2021-11-01