SecurMark SMARK-E10-SS2

GUDID 05420045503956

Hologic, Inc.

Imaging lesion localization marker, implantable

• Primary Device ID: 05420045503956
• NIH Device Record Key: 2f356c44-a0b7-4a10-9d84-6d0fcd3edad6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SecurMark
• Version Model Number: SMARK-E10-SS2
• Catalog Number: SMARK-E10-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

Customer Support Contacts

• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05420045503956 [Primary]
GS1	15420045503953 [Package]; Package: BOX [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062528

FDA Product Code

• NEU: MARKER, RADIOGRAPHIC, IMPLANTABLE

Sterilization

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

[05420045503956]

Radiation Sterilization

[05420045503956]

Radiation Sterilization

[05420045503956]

Radiation Sterilization

[05420045503956]

Radiation Sterilization

[05420045503956]

Radiation Sterilization

[05420045503956]

Radiation Sterilization

[05420045503956]

Radiation Sterilization

[05420045503956]

Radiation Sterilization

[05420045503956]

Radiation Sterilization

[05420045503956]

Radiation Sterilization

[05420045503956]

Radiation Sterilization

[05420045503956]

Radiation Sterilization

[05420045503956]

Radiation Sterilization

[05420045503956]

Radiation Sterilization

[05420045503956]

Radiation Sterilization

[05420045503956]

Radiation Sterilization

[05420045503956]

Radiation Sterilization

[05420045503956]

Radiation Sterilization

[05420045503956]

Radiation Sterilization

[05420045503956]

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: 2015-09-04

On-Brand Devices [SecurMark]

• 05420045503963: SMARK-E10-SS3
• 05420045503956: SMARK-E10-SS2
• 05420045503949: SMARK-E10-SS1
• 05420045503932: SMARK-E13-SS3
• 05420045503925: SMARK-E13-SS2
• 05420045503918: SMARK-E13-SS1
• 15420045503908: SMARK-U-SS3
• 15420045503892: SMARK-U-SS2
• 15420045503885: SMARK-U-SS1
• 05420045503628: SMARK-EVIVA-2S-13
• 05420045503611: SMARK-EVIVA-13
• 05420045503604: SMARK-EVIVA-2S-10
• 05420045503598: SMARK-EVIVA-10
• 05420045503406: SMARK-CELERO-2S
• 05420045503390: SMARK-CELERO