ATEC Needle Guide ATEC NG12-LORAD

GUDID 05420045503123

Hologic, Inc.

Side-notch biopsy gun handpiece/needle

• Primary Device ID: 05420045503123
• NIH Device Record Key: 35ee0328-1037-48f4-8ca9-2e612ca1f809
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ATEC Needle Guide
• Version Model Number: ATEC NG12-LORAD
• Catalog Number: ATEC NG12-LORAD
• Company DUNS: 018925968
• Company Name: Hologic, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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	05420045503123 [Primary]
GS1	15420045503120 [Package]; Package: BOX [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042290

FDA Product Code

• KNW: INSTRUMENT, BIOPSY

Sterilization

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

[05420045503123]

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: 2015-09-03

On-Brand Devices [ATEC Needle Guide]

• 05420045503154: ATEC_NG09-A2
• 05420045503147: ATEC NG09-A1
• 05420045503130: ATEC NG12-FISCH
• 05420045503123: ATEC NG12-LORAD
• 05420045503116: ATEC NG09-FISCH
• 05420045503109: ATEC NG09-LORAD