Benchmark MAX System

GUDID 00815948024601

BMX81 105cm

PENUMBRA, INC.

Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use
Primary Device ID00815948024601
NIH Device Record Key7c0f78a0-a7ba-43d0-ac1f-93bee043bdb4
Commercial Distribution StatusIn Commercial Distribution
Brand NameBenchmark MAX System
Version Model NumberBMX7F105-A
Company DUNS191077671
Company NamePENUMBRA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100815948024601 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQYCATHETER, PERCUTANEOUS

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-22
Device Publish Date2022-11-14

On-Brand Devices [Benchmark MAX System]

00815948023086BMX96 100cm, MP Tip, 6F SIMV 125cm Select
00815948023079BMX96 100cm, STR Tip, 6F SIMV 125cm Select
00815948023062BMX96 100cm, MP Tip, 6F BER 125cm Select
00815948023055BMX96 100cm, MP Tip, 6F H1 125cm Select
00815948023048BMX96 100cm, STR Tip, 6F H1 125cm Select
00815948023031BMX96 100cm, MP Tip, 6F SIM 125cm Select
00815948022713BMX96 100cm, 6F SIM 125cm Select
00815948022706BMX96 100cm, 6F BER 125cm Select
00815948022690BMX96 90cm, MP Tip, 6F SIMV 125cm Select
00815948022683BMX96 90cm, MP Tip, 6F SIM 125cm Select
00815948022676BMX96 90cm, MP Tip, 6F BER 125cm Select
00815948022669BMX96 90cm, 6F SIMV 125cm Select
00815948022652BMX96 90cm, 6F SIM 125cm Select
00815948022645BMX96 90cm, 6F BER 125cm Select
00815948022638BMX96 80cm, 6F BER 105cm Select
00815948022621BMX96 100cm
00815948022614BMX96 90cm
00815948022607BMX96 80cm
00815948024670BMX81 95cm, MP Tip
00815948024663BMX81 95cm
00815948024656BMX81 95cm, MP Tip, 5F BER 120cm Select
00815948024649BMX81 95cm, 5F BER 120cm Select
00815948024632BMX81 95cm, MP Tip, 5F SIM 120cm Select
00815948024625BMX81 95cm, 5F SIM 120cm Select
00815948024618BMX81 105cm, MP Tip
00815948024601BMX81 105cm
00815948024595BMX81 105cm, MP Tip, 5F BER 130cm Select
00815948024588BMX81 105cm, 5F BER 130cm Select
00815948024571BMX81 105cm, MP Tip, 5F SIM 130cm Select
00815948024564BMX81 105cm, 5F SIM 130cm Select
00815948024557BMX81 115cm, MP Tip
00815948024540BMX81 115cm
00815948024533BMX81 115cm, MP Tip, 5F BER 130cm Select
00815948024526BMX81 115cm, 5F BER 130cm Select
00815948024519BMX81 115cm, MP Tip, 5F SIM 130cm Select
00815948024502BMX81 115cm, 5F SIM 130cm Select
00815948026384BMX96 80cm, STR Tip
00815948026377BMX96 80cm, STR Tip, 6F BER 105cm Select
00815948026360BMX96 90cm, STR Tip
00815948026353BMX96 90cm, MP Tip, 6F SIMV 125cm Select
00815948026346BMX96 90cm, STR Tip, 6F SIMV 125cm Select
00815948026339BMX96 90cm, MP Tip, 6F BER 125cm Select
00815948026322BMX96 90cm, STR Tip, 6F BER 125cm Select
00815948026315BMX96 90cm, MP Tip, 6F SIM 125cm Select
00815948026308BMX96 90cm, STR Tip, 6F SIM 125cm Select
00815948026292BMX96 100cm, STR Tip
00815948026285BMX96 100cm, MP Tip, 6F SIMV 125cm Select
00815948026278BMX96 100cm, STR Tip, 6F SIMV 125cm Select
00815948026261BMX96 100cm, MP Tip, 6F BER 125cm Select
00815948026254BMX96 100cm, STR Tip, 6F BER 125cm Select

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