SemiCut Coax. PD0PP1415

GUDID 08052440106073

DISPOSABLE SEMIAUTOMATIC GUILLOTINE NEEDLE 14G X 150 mm FOR SOFT TISSUE BIOPSY WITHOUT REMOVABLE LUER, WITH INTRODUCER

MDL SRL

End-cut biopsy gun handpiece/needle End-cut biopsy gun handpiece/needle End-cut biopsy gun handpiece/needle End-cut biopsy gun handpiece/needle End-cut biopsy gun handpiece/needle End-cut biopsy gun handpiece/needle End-cut biopsy gun handpiece/needle End-cut biopsy gun handpiece/needle End-cut biopsy gun handpiece/needle End-cut biopsy gun handpiece/needle End-cut biopsy gun handpiece/needle End-cut biopsy gun handpiece/needle End-cut biopsy gun handpiece/needle End-cut biopsy gun handpiece/needle End-cut biopsy gun handpiece/needle End-cut biopsy gun handpiece/needle End-cut biopsy gun handpiece/needle End-cut biopsy gun handpiece/needle End-cut biopsy gun handpiece/needle End-cut biopsy gun handpiece/needle End-cut biopsy gun handpiece/needle End-cut biopsy gun handpiece/needle End-cut biopsy gun handpiece/needle End-cut biopsy gun handpiece/needle End-cut biopsy gun handpiece/needle End-cut biopsy gun handpiece/needle End-cut biopsy gun handpiece/needle End-cut biopsy gun handpiece/needle End-cut biopsy gun handpiece/needle End-cut biopsy gun handpiece/needle

• Primary Device ID: 08052440106073
• NIH Device Record Key: 0a87ae98-64c7-46d9-9c20-a00fc11e9e70
• Commercial Distribution Discontinuation: 2021-04-26
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SemiCut Coax.
• Version Model Number: PD0PP1415
• Catalog Number: PD0PP1415
• Company DUNS: 447228586
• Company Name: MDL SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08052440106073 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160316

FDA Product Code

• FCG: Biopsy Needle

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: 2021-05-04
• Device Publish Date: 2021-04-26

On-Brand Devices [SemiCut Coax.]

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• 08058341217313: DISPOSABLE SEMIAUTOMATIC GUILLOTINE NEEDLE 14G X 70 mm FOR SOFT TISSUE BIOPSY WITHOUT REMOVABLE
• 08052440108145: DISPOSABLE SEMIAUTOMATIC GUILLOTINE NEEDLE 16G X 150 mm FOR SOFT TISSUE BIOPSY WITHOUT REMOVABLE
• 08052440106073: DISPOSABLE SEMIAUTOMATIC GUILLOTINE NEEDLE 14G X 150 mm FOR SOFT TISSUE BIOPSY WITHOUT REMOVABLE
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• 18056138585734: DISPOSABLE SEMIAUTOMATIC GUILLOTINE NEEDLE 20G X 100 mm FOR SOFT TISSUE BIOPSY WITHOUT REMOVABLE
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• 18056138585673: DISPOSABLE SEMIAUTOMATIC GUILLOTINE NEEDLE 18G X 70 mm FOR SOFT TISSUE BIOPSY WITHOUT REMOVABLE
• 18056138585666: DISPOSABLE SEMIAUTOMATIC GUILLOTINE NEEDLE 16G X 200 mm FOR SOFT TISSUE BIOPSY WITHOUT REMOVABLE
• 18056138585659: DISPOSABLE SEMIAUTOMATIC GUILLOTINE NEEDLE 16G X 160 mm FOR SOFT TISSUE BIOPSY WITHOUT REMOVABLE
• 18056138585642: DISPOSABLE SEMIAUTOMATIC GUILLOTINE NEEDLE 16G X 150 mm FOR SOFT TISSUE BIOPSY WITHOUT REMOVABLE
• 18056138585635: DISPOSABLE SEMIAUTOMATIC GUILLOTINE NEEDLE 16G X 100 mm FOR SOFT TISSUE BIOPSY WITHOUT REMOVABLE
• 18056138585628: DISPOSABLE SEMIAUTOMATIC GUILLOTINE NEEDLE 14G X 200 mm FOR SOFT TISSUE BIOPSY WITHOUT REMOVABLE
• 18056138585611: DISPOSABLE SEMIAUTOMATIC GUILLOTINE NEEDLE 14G X 160 mm FOR SOFT TISSUE BIOPSY WITHOUT REMOVABLE
• 18056138585604: DISPOSABLE SEMIAUTOMATIC GUILLOTINE NEEDLE 14G X 150 mm FOR SOFT TISSUE BIOPSY WITHOUT REMOVABLE
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