TriMark TRIMARKTD-2S-13-MR

GUDID 05420045503345

Hologic, Inc.

Imaging lesion localization marker, implantable

• Primary Device ID: 05420045503345
• NIH Device Record Key: 3ccbbc76-35f6-43f6-b5c4-17be5a06298d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TriMark
• Version Model Number: TRIMARKTD-2S-13-MR
• Catalog Number: TRIMARKTD-2S-13-MR
• Company DUNS: 018925968
• Company Name: Hologic, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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	05420045503345 [Primary]
GS1	15420045503342 [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

[05420045503345]

Radiation Sterilization

[05420045503345]

Radiation Sterilization

[05420045503345]

Radiation Sterilization

[05420045503345]

Radiation Sterilization

[05420045503345]

Radiation Sterilization

[05420045503345]

Radiation Sterilization

[05420045503345]

Radiation Sterilization

[05420045503345]

Radiation Sterilization

[05420045503345]

Radiation Sterilization

[05420045503345]

Radiation Sterilization

[05420045503345]

Radiation Sterilization

[05420045503345]

Radiation Sterilization

[05420045503345]

Radiation Sterilization

[05420045503345]

Radiation Sterilization

[05420045503345]

Radiation Sterilization

[05420045503345]

Radiation Sterilization

[05420045503345]

Radiation Sterilization

[05420045503345]

Radiation Sterilization

[05420045503345]

Radiation Sterilization

[05420045503345]

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