FreeClimb 54 reperfusion catheter, 148cm with Tenzing 5 REF 7001-54-148R

GUDID 00853799007688

FreeClimb 54 reperfusion catheter, 148cm with Tenzing 5: Contains Tenzing 5 delivery Catheter (00853799007619) and FreeClimb 54 catheter, 148cm (00853799007626)

ROUTE 92 MEDICAL

Thrombectomy suction catheter
Primary Device ID00853799007688
NIH Device Record Keya377245c-a1e6-414d-a15b-0ed00042375d
Commercial Distribution StatusIn Commercial Distribution
Brand NameFreeClimb 54 reperfusion catheter, 148cm with Tenzing 5
Version Model NumberGen 1
Catalog NumberREF 7001-54-148R
Company DUNS067429673
Company NameROUTE 92 MEDICAL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone650-350-9416
EmailCustomerservice@r92m.com
Phone650-350-9416
EmailCustomerservice@r92m.com
Phone650-350-9416
EmailCustomerservice@r92m.com
Phone650-350-9416
EmailCustomerservice@r92m.com
Phone650-350-9416
EmailCustomerservice@r92m.com
Phone650-350-9416
EmailCustomerservice@r92m.com
Phone650-350-9416
EmailCustomerservice@r92m.com
Phone650-350-9416
EmailCustomerservice@r92m.com
Phone650-350-9416
EmailCustomerservice@r92m.com
Phone650-350-9416
EmailCustomerservice@r92m.com
Phone650-350-9416
EmailCustomerservice@r92m.com
Phone650-350-9416
EmailCustomerservice@r92m.com
Phone650-350-9416
EmailCustomerservice@r92m.com
Phone650-350-9416
EmailCustomerservice@r92m.com
Phone650-350-9416
EmailCustomerservice@r92m.com
Phone650-350-9416
EmailCustomerservice@r92m.com
Phone650-350-9416
EmailCustomerservice@r92m.com
Phone650-350-9416
EmailCustomerservice@r92m.com
Phone650-350-9416
EmailCustomerservice@r92m.com
Phone650-350-9416
EmailCustomerservice@r92m.com
Phone650-350-9416
EmailCustomerservice@r92m.com
Phone650-350-9416
EmailCustomerservice@r92m.com
Phone650-350-9416
EmailCustomerservice@r92m.com
Phone650-350-9416
EmailCustomerservice@r92m.com
Phone650-350-9416
EmailCustomerservice@r92m.com
Phone650-350-9416
EmailCustomerservice@r92m.com
Phone650-350-9416
EmailCustomerservice@r92m.com
Phone650-350-9416
EmailCustomerservice@r92m.com
Phone650-350-9416
EmailCustomerservice@r92m.com
Phone650-350-9416
EmailCustomerservice@r92m.com
Phone650-350-9416
EmailCustomerservice@r92m.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100853799007688 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NRYCatheter, Thrombus Retriever

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-07
Device Publish Date2024-05-30

Devices Manufactured by ROUTE 92 MEDICAL

00853799007701 - 8F Base Camp system 2.0 80cm2024-10-22 8F Base Camp system 2.0 80cm
00853799007718 - 8F Base Camp system 2.0 80cm2024-10-22 8F Base Camp system 2.0 80cm; Contains 8F Base Camp system 2.0 80cm (00853799007701)
00853799007725 - 8F Base Camp system 2.0 90cm2024-10-22 8F Base Camp system 2.0 90cm
00853799007732 - 8F Base Camp system 2.0 90cm2024-10-22 8F Base Camp system 2.0 90cm; 8F Base Camp system 2.0 90cm (00853799007725)
00853799007749 - FreeClimb 88 catheter, 125cm2024-07-09 FreeClimb 88 catheter, 125cm
00853799007756 - FreeClimb 88 catheter, 132cm2024-07-09 FreeClimb 88 catheter, 132cm
00853799007763 - FreeClimb 88 catheter, 125cm with Tenzing 82024-07-09 FreeClimb 88 catheter, 125cm with Tenzing 8; Contains Tenzing 8 Delivery Catheter (00853799007299) and FreeClimb 88 catheter, 12
00853799007770 - FreeClimb 88 catheter, 132cm with Tenzing 82024-07-09 FreeClimb 88 catheter, 132cm with Tenzing 8; Contains Tenzing 8 Delivery Catheter (00853799007299) and FreeClimb 88 catheter, 13

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