SecurMark for ATEC SMARK-ATEC-2S-36-09

GUDID 05420045503468

Hologic, Inc.

Imaging lesion localization marker, implantable

• Primary Device ID: 05420045503468
• NIH Device Record Key: 76de8dfd-0021-4c16-8f48-3b85f9c906fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SecurMark for ATEC
• Version Model Number: SMARK-ATEC-2S-36-09
• Catalog Number: SMARK-ATEC-2S-36-09
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05420045503468 [Primary]
GS1	15420045503465 [Package]; Package: BOX [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072913

FDA Product Code

• NEU: MARKER, RADIOGRAPHIC, IMPLANTABLE

Sterilization

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

[05420045503468]

Radiation Sterilization

[05420045503468]

Radiation Sterilization

[05420045503468]

Radiation Sterilization

[05420045503468]

Radiation Sterilization

[05420045503468]

Radiation Sterilization

[05420045503468]

Radiation Sterilization

[05420045503468]

Radiation Sterilization

[05420045503468]

Radiation Sterilization

[05420045503468]

Radiation Sterilization

[05420045503468]

Radiation Sterilization

[05420045503468]

Radiation Sterilization

[05420045503468]

Radiation Sterilization

[05420045503468]

Radiation Sterilization

[05420045503468]

Radiation Sterilization

[05420045503468]

Radiation Sterilization

[05420045503468]

Radiation Sterilization

[05420045503468]

Radiation Sterilization

[05420045503468]

Radiation Sterilization

[05420045503468]

Radiation Sterilization

[05420045503468]

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