Smart Coil

GUDID 00814548014647

SmtCoil-Std, 5x15

PENUMBRA, INC.

Embolization implant kit

• Primary Device ID: 00814548014647
• NIH Device Record Key: 8fcc2c23-de37-4a1a-bca7-213c63f748ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smart Coil
• Version Model Number: 400SMTSTD0515
• 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: 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	00814548014647 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143218

FDA Product Code

• HCG: DEVICE, NEUROVASCULAR EMBOLIZATION

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-30

On-Brand Devices [Smart Coil]

• 00814548017396: 400SMTHXSFT4H20
• 00814548017389: 400SMTHXSFT4H15
• 00814548017372: 400SMTHXSFT4H12
• 00814548017365: 400SMTHXSFT4H10
• 00814548017358: 400SMTHXSFT4H08
• 00814548017341: 400SMTHXSFT4H06
• 00814548017334: 400SMTHXSFT0420
• 00814548017327: 400SMTHXSFT3H15
• 00814548017310: 400SMTHXSFT3H12
• 00814548017303: 400SMTHXSFT3H10
• 00814548017297: 400SMTHXSFT3H08
• 00814548017280: 400SMTHXSFT3H06
• 00814548017273: 400SMTHXSFT3H04
• 00814548017266: 400SMTHXSFT2H10
• 00814548017259: 400SMTHXSFT2H09
• 00814548017242: 400SMTHXSFT0210
• 00814548017235: 400SMTHXSFT0209
• 00814548017228: 400SMTXSFT4H20
• 00814548017211: 400SMTXSFT4H15
• 00814548017204: 400SMTXSFT4H12
• 00814548017198: 400SMTXSFT4H10
• 00814548017181: 400SMTXSFT4H08
• 00814548017174: 400SMTXSFT4H06
• 00814548017167: 400SMTXSFT0420
• 00814548017150: 400SMTXSFT3H15
• 00814548017143: 400SMTXSFT3H12
• 00814548017136: 400SMTXSFT3H10
• 00814548017129: 400SMTXSFT3H08
• 00814548017112: 400SMTXSFT3H06
• 00814548017105: 400SMTXSFT3H04
• 00814548017099: 400SMTXSFT2H10
• 00814548017082: 400SMTXSFT2H09
• 00814548017075: 400SMTXSFT0210
• 00814548017068: 400SMTXSFT0209
• 00814548017051: 400SMTSFT4H10
• 00814548017044: 400SMTSFT4H08
• 00814548017037: 400SMTSFT4H06
• 00814548017020: 400SMTSFT3H10
• 00814548017013: 400SMTSFT3H08
• 00814548017006: 400SMTSFT3H06
• 00814548016993: 400SMTSFT3H04
• 00814548016986: 400SMTSFT2H06
• 00814548016979: 400SMTSFT2H05
• 00814548016962: 400SMTSFT4H20
• 00814548016955: 400SMTSFT4H15
• 00814548016948: 400SMTSFT4H12
• 00814548016931: 400SMTSFT0420
• 00814548016924: 400SMTSTD4H20
• 00814548016917: 400SMTSTD4H15
• 00814548016900: 400SMTSTD4H12