Neuron

GUDID 00815948027886

Neur070Select, 130SIM

PENUMBRA, INC.

Vascular microcatheter

• Primary Device ID: 00815948027886
• NIH Device Record Key: e42f1bf1-d523-4120-ba58-d24270e3ce73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neuron
• Version Model Number: PNS5F130SIM-R
• Company DUNS: 191077671
• Company Name: PENUMBRA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815948027886 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083125

FDA Product Code

• DQY: CATHETER, PERCUTANEOUS

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-30
• Device Publish Date: 2023-05-22

On-Brand Devices [Neuron]

• 00814548012377: NeurMAX088, 100STR
• 00814548012360: NeurMAX088, 100MP
• 00814548012353: NeurMAX088, 70STR
• 00814548012346: NeurMAX088, 70MP
• 00814548012339: NeurMAX088, 80STR
• 00814548012322: NeurMAX088, 80MP
• 00814548012315: NeurMAX088, 90STR
• 00814548012308: NeurMAX088, 90MP
• 00814548012292: NeurMAX088 DL04, 100STR
• 00814548012285: NeurMAX088 DL04, 100MP
• 00814548012278: NeurMAX088DL05, 100MP
• 00814548012261: NeurMAX088DL05, 100STR
• 00814548012254: NeurMAX088DL01, 80STR
• 00814548012247: NeurMAX088DL01, 70MP
• 00814548012230: NeurMAX088DL02, 70MP
• 00814548012223: NeurMAX088DL02, 70STR
• 00814548012216: NeurMAX088DL02, 80STR
• 00814548012209: NeurMAX088DL02, 80MP
• 00814548012193: NeurMAX088DL03, 80MP
• 00814548012186: NeurMAX088DL04, 80STR
• 00814548012179: NeurMAX088DL05, 90STR
• 00814548012162: NeurMAX088DL06, 90MP
• 00814548012155: NeurMAX088DL04, 90MP
• 00814548012148: NeurMAX088DL05, 90STR
• 00814548012131: Neur6F, 105BER
• 00814548012124: Neur6F, 105H1
• 00814548012117: Neur6F, 105SIM
• 00814548012100: Neur6F, 105SIMV
• 00814548012094: Neur6F, 125BER
• 00814548012087: Neur6F, 125H1
• 00814548012070: Neur6F, 125SIM
• 00814548012063: Neur6F, 125SIMV
• 00814548010236: Neur070Select, 130SIM
• 00814548010229: Neur070Select, 130H1
• 00814548010212: Neur070Select, 130BER
• 00814548010205: Neur070Select, 120SIM
• 00814548010199: Neur070Select, 120H1
• 00814548010182: Neur070Select, 120BER
• 00814548010151: Neur6F DC MP, 115x6
• 00814548010144: Neur6F DC STR, 115x6
• 00814548010137: Neur6F DC MP, 115x12
• 00814548010120: Neur6F DC STR, 115x12
• 00814548010113: Neur6F DC MP, 105x6
• 00814548010106: Neur6F DC STR, 105x6
• 00814548010090: Neur6F DC MP, 105x12
• 00814548010083: Neur6F DC STR, 105x12
• 00814548010076: Neur070 DC SHP, 95x6
• 00814548010069: Neur070 DC STR, 95x6
• 00814548010052: Neur070 DC SHP, 105x8
• 00814548010045: Neur070 DC STR, 105x8