CoreTainer

GUDID 00815137021145

Stereotactic Core Biopsy Image and Transport System

Beekley Corporation

General specimen container IVD, no additive, non-sterile

• Primary Device ID: 00815137021145
• NIH Device Record Key: 4c704b27-54cb-4816-a4a6-e8426206328a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoreTainer
• Version Model Number: 301
• Company DUNS: 001157841
• Company Name: Beekley Corporation
• Device Count: 12
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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	00815137021145 [Primary]
GS1	10815137021142 [Unit of Use]

FDA Product Code

• NNI: Container, Specimen, Non-Sterile

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-30
• Device Publish Date: 2019-07-22

On-Brand Devices [CoreTainer]

• 00815137022036: Stereotactic Core Biopsy Image and Transport System
• 00815137022029: Stereotactic Core Biopsy Image and Transport System
• 00815137021589: Stereotactic Core Biopsy Image and Transport System
• 00815137021145: Stereotactic Core Biopsy Image and Transport System