CoreTainer

GUDID 00815137021145

Stereotactic Core Biopsy Image and Transport System

Beekley Corporation

General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium

• 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