MEDWIRE

GUDID 18052286425861

Repositionable system for localization of non palpable breast lesions 20G x 90mm O Type

MEDAX SRL UNIPERSONALE

Imaging lesion localization marker, external, single-use

• Primary Device ID: 18052286425861
• NIH Device Record Key: 424b7c19-958b-4290-9df0-cdd9d5168355
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDWIRE
• Version Model Number: XW20090-0O
• Company DUNS: 440211428
• Company Name: MEDAX SRL UNIPERSONALE
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08052286425864 [Primary]
GS1	18052286425861 [Package]; Contains: 08052286425864; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• MIJ: Needle, Tumor Localization

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-05
• Device Publish Date: 2020-12-28

On-Brand Devices [MEDWIRE]

• 18052286425908: Repositionable system for localization of non palpable breast lesions 20G x 70mm J Type
• 18052286425892: Repositionable system for localization of non palpable breast lesions 20G x 50mm J Type
• 18052286425885: Repositionable system for localization of non palpable breast lesions 20G x 30mm J Type
• 18052286425878: Repositionable system for localization of non palpable breast lesions 20G x 120mm O Type
• 18052286425861: Repositionable system for localization of non palpable breast lesions 20G x 90mm O Type
• 18052286425854: Repositionable system for localization of non palpable breast lesions 20G x 60mm O Type
• 18052286428275: Repositionable system for localization of non palpable breast lesions 20G x 100mm J Type
• 18059174746985: Non-repositionable system for preoperative localization of non palpable breast lesions 20G x 100