Mammotome MammoTest G1621

GUDID 00841911101758

Fischer Probe Guide Holder

DEVICOR MEDICAL PRODUCTS, INC.

Nonimplantable needle guide, reusable

• Primary Device ID: 00841911101758
• NIH Device Record Key: f38f88ee-c071-4306-8aa8-c6d317f1ac39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mammotome MammoTest
• Version Model Number: G1621
• Catalog Number: G1621
• Company DUNS: 961832156
• Company Name: DEVICOR MEDICAL PRODUCTS, INC.
• Device Count: 1
• DM Exempt: false
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 877-926-2666
• Email: customersupport@mammotome.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841911101208 [Primary]
GS1	00841911101758 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K943863

FDA Product Code

• IYN: System, Imaging, Pulsed Doppler, Ultrasonic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-12-23
• Device Publish Date: 2018-10-10

On-Brand Devices [Mammotome MammoTest]

• 00841911101581: Stereotactic X-Ray Breast Biopsy Table System
• 00841911101215: Probe Guide Holder Lateral
• 00841911101758: Fischer Probe Guide Holder
• 00841911100539: Stereotactic Adapter