SecurMark for ATEC SMARK-A1312-SS2

GUDID 05420045503857

Hologic, Inc.

Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable

• Primary Device ID: 05420045503857
• NIH Device Record Key: 67c34f3b-a2bb-47cc-8324-a21a272e4879
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SecurMark for ATEC
• Version Model Number: SMARK-A1312-SS2
• Catalog Number: SMARK-A1312-SS2
• Company DUNS: 018925968
• Company Name: Hologic, Inc.
• Device Count: 1
• DM Exempt: true
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05420045503857 [Primary]
GS1	15420045503854 [Package]; Package: BOX [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102608

FDA Product Code

• NEU: MARKER, RADIOGRAPHIC, IMPLANTABLE

Sterilization

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

[05420045503857]

Radiation Sterilization

[05420045503857]

Radiation Sterilization

[05420045503857]

Radiation Sterilization

[05420045503857]

Radiation Sterilization

[05420045503857]

Radiation Sterilization

[05420045503857]

Radiation Sterilization

[05420045503857]

Radiation Sterilization

[05420045503857]

Radiation Sterilization

[05420045503857]

Radiation Sterilization

[05420045503857]

Radiation Sterilization

[05420045503857]

Radiation Sterilization

[05420045503857]

Radiation Sterilization

[05420045503857]

Radiation Sterilization

[05420045503857]

Radiation Sterilization

[05420045503857]

Radiation Sterilization

[05420045503857]

Radiation Sterilization

[05420045503857]

Radiation Sterilization

[05420045503857]

Radiation Sterilization

[05420045503857]

Radiation Sterilization

[05420045503857]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-08-29

On-Brand Devices [SecurMark for ATEC]

• 05420045503871: SMARK-A1309-SS2
• 05420045503864: SMARK-A1309-SS1
• 05420045503857: SMARK-A1312-SS2
• 05420045503840: SMARK-A1312-SS1
• 05420045503833: SMARK-A3609-SS3
• 05420045503826: SMARK-A3609-SS2
• 05420045503819: SMARK-A3609-SS1
• 05420045503482: SMARK-ATEC-2S-36-12
• 05420045503475: SMARK-ATEC-36-12
• 05420045503468: SMARK-ATEC-2S-36-09
• 05420045503451: SMARK-ATEC-36-09
• 05420045503444: SMARK-ATEC-2S-13-12
• 05420045503437: SMARK-ATEC-13-12
• 05420045503420: SMARK-ATEC-2S-13-09
• 05420045503413: SMARK-ATEC-13-09