TriMark TRIMARKTD-2S-13-12

GUDID 05420045503338

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 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 Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable

• Primary Device ID: 05420045503338
• NIH Device Record Key: 96a44e68-0aa2-4733-9852-108eddff52db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TriMark
• Version Model Number: TRIMARKTD-2S-13-12
• Catalog Number: TRIMARKTD-2S-13-12
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 and 15 Degrees Celsius
• Handling Environment Temperature: Between 0 and 15 Degrees Celsius
• Handling Environment Temperature: Between 0 and 15 Degrees Celsius
• Handling Environment Temperature: Between 0 and 15 Degrees Celsius
• Handling Environment Temperature: Between 0 and 15 Degrees Celsius
• Handling Environment Temperature: Between 0 and 15 Degrees Celsius
• Handling Environment Temperature: Between 0 and 15 Degrees Celsius
• Handling Environment Temperature: Between 0 and 15 Degrees Celsius
• Handling Environment Temperature: Between 0 and 15 Degrees Celsius
• Handling Environment Temperature: Between 0 and 15 Degrees Celsius
• Handling Environment Temperature: Between 0 and 15 Degrees Celsius
• Handling Environment Temperature: Between 0 and 15 Degrees Celsius
• Handling Environment Temperature: Between 0 and 15 Degrees Celsius
• Handling Environment Temperature: Between 0 and 15 Degrees Celsius
• Handling Environment Temperature: Between 0 and 15 Degrees Celsius
• Handling Environment Temperature: Between 0 and 15 Degrees Celsius
• Handling Environment Temperature: Between 0 and 15 Degrees Celsius
• Handling Environment Temperature: Between 0 and 15 Degrees Celsius
• Handling Environment Temperature: Between 0 and 15 Degrees Celsius
• Handling Environment Temperature: Between 0 and 15 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05420045503338 [Primary]
GS1	15420045503335 [Package]; Package: BOX [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023450

FDA Product Code

• NEU: MARKER, RADIOGRAPHIC, IMPLANTABLE

Sterilization

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

[05420045503338]

Radiation Sterilization

[05420045503338]

Radiation Sterilization

[05420045503338]

Radiation Sterilization

[05420045503338]

Radiation Sterilization

[05420045503338]

Radiation Sterilization

[05420045503338]

Radiation Sterilization

[05420045503338]

Radiation Sterilization

[05420045503338]

Radiation Sterilization

[05420045503338]

Radiation Sterilization

[05420045503338]

Radiation Sterilization

[05420045503338]

Radiation Sterilization

[05420045503338]

Radiation Sterilization

[05420045503338]

Radiation Sterilization

[05420045503338]

Radiation Sterilization

[05420045503338]

Radiation Sterilization

[05420045503338]

Radiation Sterilization

[05420045503338]

Radiation Sterilization

[05420045503338]

Radiation Sterilization

[05420045503338]

Radiation Sterilization

[05420045503338]

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 [TriMark]

• 05420045503581: TRIMARK-EVIVA-2S-13
• 05420045503574: TRIMARK-EVIVA-13
• 05420045503567: TRIMARK-EVIVA-2S-10
• 05420045503550: TRIMARK-EVIVA-10
• 05420045503369: TRIMARKTD-2S-36-12
• 05420045503352: TRIMARKTD-2S-36-09
• 05420045503345: TRIMARKTD-2S-13-MR
• 05420045503338: TRIMARKTD-2S-13-12
• 05420045503321: TRIMARKTD-2S-13-09
• 05420045503314: TRIMARK TD 3612
• 05420045503307: TRIMARK TD 3609
• 05420045503291: TRIMARK TD 13MR
• 05420045503284: TRIMARK TD 1312
• 05420045503277: TRIMARK TD 1309