Benchmark

GUDID 00815948025257

Benchmark Catheter (6F 105 cm x MP / 5F SEL: 130 cm x SIM)

PENUMBRA, INC.

Vascular microcatheter

• Primary Device ID: 00815948025257
• NIH Device Record Key: f4907d87-7228-484a-aeec-5e2216d33d01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Benchmark
• Version Model Number: BMK6F105MSIM130-A
• 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: true
• 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	00815948025257 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142321

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: 2023-01-13
• Device Publish Date: 2023-01-05

On-Brand Devices [Benchmark]

• 00814548014241: Bmk70 STR, 130SIM, 95cm
• 00814548014234: Bmk70 STR, 120SIM, 95cm
• 00814548014227: Bmk70 MP, 130SIM, 95cm
• 00814548014210: Bmk70 MP, 120SIM, 95cm
• 00814548014203: Bmk70 MP, 130H1, 95cm
• 00814548014197: Bmk70 MP, 120H1, 95cm
• 00814548014180: Bmk70 MP, 130BER, 95cm
• 00814548014173: Bmk70 MP, 120BER, 95cm
• 00814548014166: Bmk70 MP, 95cm
• 00814548014159: Bmk70 STR, 130H1, 95cm
• 00814548014142: Bmk70 STR, 120H1, 95cm
• 00814548014135: Bmk70 STR, 130BER, 95cm
• 00814548014128: Bmk70 STR, 120BER, 95cm
• 00814548014111: Bmk70 STR, 95cm
• 00814548014104: Bmk70 MP, 115cm
• 00814548014098: Bmk70 STR, 115cm
• 00814548014081: Bmk70 STR, 130SIM, 105cm
• 00814548014074: Bmk70 MP, 130SIM, 105cm
• 00814548014067: Bmk70 MP, 130H1, 105cm
• 00814548014050: Bmk70 MP, 130BER, 105cm
• 00814548014043: Bmk70 MP, 105cm
• 00814548014036: Bmk70 STR, 130H1, 105cm
• 00814548014029: Bmk70 STR, 130BER, 105cm
• 00814548014012: Bmk70 STR, 105cm
• 00815948025257: Benchmark Catheter (6F 105 cm x MP / 5F SEL: 130 cm x SIM)
• 00815948025240: Benchmark Catheter (6F 105 cm x MP / 5F SEL: 130 cm x BER)
• 00815948025233: Benchmark Catheter (6F 105 cm x STR / 5F SEL: 130 cm x SIM)
• 00815948025226: Benchmark Catheter (6F 105 cm x STR / 5F SEL: 130 cm x BER)
• 00815948025219: Benchmark Catheter (6F 95 cm x MP / 5F SEL: 120 cm x SIM)
• 00815948025202: Benchmark Catheter (6F 95 cm x MP / 5F SEL: 120 cm x BER)
• 00815948025196: Benchmark Catheter (6F 95 cm x STR / 5F SEL: 120 cm x SIM)
• 00815948025189: Benchmark Catheter (6F 95 cm x STR / 5F SEL: 120 cm x BER)
• 00815948025172: Benchmark Catheter (6F 115 cm x MP)
• 00815948025165: Benchmark Catheter (6F 115 cm x STR)
• 00815948025158: Benchmark Catheter (6F 105 cm x MP)
• 00815948025141: Benchmark Catheter (6F 105 cm x STR)
• 00815948025134: Benchmark Catheter (6F 95 cm x MP)
• 00815948025127: Benchmark Catheter (6F 95 cm x STR)