M-Core

GUDID B567MC18250

Disposable Core Biopsy Needle

INSERT MOLDING SOLUTIONS INC

End-cut biopsy gun handpiece/needle

• Primary Device ID: B567MC18250
• NIH Device Record Key: 5355aa8f-d0e4-411a-bea6-3de4d9689042
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: M-Core
• Version Model Number: MC1825
• Company DUNS: 031736504
• Company Name: INSERT MOLDING SOLUTIONS 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: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B567MC18250 [Primary]
HIBCC	B567MC18251 [Package]; Package: Box [10 Units]; In Commercial Distribution

FDA Product Code

• KNW: Instrument, Biopsy

Sterilization

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

[B567MC18250]

Radiation Sterilization

[B567MC18250]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-11
• Device Publish Date: 2019-02-08

Devices Manufactured by INSERT MOLDING SOLUTIONS INC

• B567AU170 - BioFlo: 2019-03-11 BioFlo AutoValve Urine Valve
• B567MC18200 - M Core: 2019-03-11 Biopsy Needle
• B567MC18250 - M-Core: 2019-03-11Disposable Core Biopsy Needle
• B567MC18250 - M-Core: 2019-03-11 Disposable Core Biopsy Needle