Penumbra Coil 400 4002C0615

GUDID 00814548018928

Coil 400 Standard, 6x15

PENUMBRA, INC.

Embolization implant kit

• Primary Device ID: 00814548018928
• NIH Device Record Key: 2162236a-e021-4bac-abbb-07f8449fc1d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Penumbra Coil 400
• Version Model Number: 4002C0615-A
• Catalog Number: 4002C0615
• Company DUNS: 191077671
• Company Name: PENUMBRA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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	00814548018928 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173614

FDA Product Code

• HCG: DEVICE, NEUROVASCULAR EMBOLIZATION

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-16

On-Brand Devices [Penumbra Coil 400]

• 00814548019697: Coil 400 Soft, 9x30
• 00814548019680: Coil 400 Curve, 6x30
• 00814548019574: Coil 400 Curve, 4x10
• 00814548019567: Coil 400 Curve, 4x8
• 00814548019550: Coil 400 Curve, 4x6
• 00814548019543: Coil 400 Curve, 4x4
• 00814548019536: Coil 400 Curve, 3x8
• 00814548019529: Coil 400 Curve, 3x6
• 00814548019512: Coil 400 Curve, 3x5
• 00814548019505: Coil 400 Curve, 3x4
• 00814548019499: Coil 400 Curve, 3x3
• 00814548019482: Coil 400 Curve, 3x2
• 00814548019475: Coil 400 Curve, 2x4
• 00814548019468: Coil 400 Curve, 2x3
• 00814548019451: Coil 400 Curve, 2x2
• 00814548019444: Coil 400 Curve, 2x1
• 00814548019413: Coil 400 Standard, 32x60
• 00814548019406: Coil 400 Standard, 28x60
• 00814548019383: Coil 400 Standard, 24x60
• 00814548019376: Coil 400 Standard, 22x60
• 00814548019369: Coil 400 Standard, 20x60
• 00814548019345: Coil 400 Standard, 18x60
• 00814548019338: Coil 400 Standard, 16x60
• 00814548019246: Coil 400 Soft, 18x45
• 00814548019222: Coil 400 Standard, 15x60
• 00814548019215: Coil 400 Standard, 14x50
• 00814548019208: Coil 400 Standard, 13x48
• 00814548019192: Coil 400 Standard, 12x45
• 00814548019185: Coil 400 Standard, 12x35
• 00814548019178: Coil 400 Standard, 11x45
• 00814548019161: Coil 400 Standard, 11x35
• 00814548019154: Coil 400 Standard, 10x40
• 00814548019147: Coil 400 Standard, 10x30
• 00814548019130: Coil 400 Standard, 10x20
• 00814548019055: Coil 400 Soft, 16x45
• 00814548019048: Coil 400 Soft, 15x45
• 00814548019031: Coil 400 Soft, 14x40
• 00814548019024: Coil 400 Soft, 13x35
• 00814548019017: Coil 400 Soft, 12x35
• 00814548019000: Coil 400 Standard, 9x35
• 00814548018997: Coil 400 Standard, 9x25
• 00814548018980: Coil 400 Standard, 8x30
• 00814548018973: Coil 400 Standard, 8x20
• 00814548018966: Coil 400 Standard, 7x20
• 00814548018959: Coil 400 Standard, 7x15
• 00814548018942: Coil 400 Standard, 7x10
• 00814548018935: Coil 400 Standard, 6x20
• 00814548018928: Coil 400 Standard, 6x15
• 00814548018911: Coil 400 Standard, 6x10
• 00814548018782: Coil 400 Soft, 11x35