Palium PL

GUDID 08056138586109

REUSABLE AUTOMATIC BIOPSY INSTRUMENT

MDL SRL

Biopsy gun handpiece Biopsy gun handpiece Biopsy gun handpiece Biopsy gun handpiece Biopsy gun handpiece Biopsy gun handpiece Biopsy gun handpiece Biopsy gun handpiece Biopsy gun handpiece Biopsy gun handpiece Biopsy gun handpiece Biopsy gun handpiece Biopsy gun handpiece Biopsy gun handpiece Biopsy gun handpiece Biopsy gun handpiece Biopsy gun handpiece Biopsy gun handpiece Biopsy gun handpiece Biopsy gun handpiece Biopsy gun handpiece Biopsy gun handpiece Biopsy gun handpiece Biopsy gun handpiece Biopsy gun handpiece Biopsy gun handpiece Biopsy gun handpiece Biopsy gun handpiece Biopsy gun handpiece Biopsy gun handpiece Biopsy gun handpiece

• Primary Device ID: 08056138586109
• NIH Device Record Key: 40e67c55-e4a3-475e-a4ef-2a730121fc94
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Palium
• Version Model Number: PL
• Catalog Number: PL
• 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08056138586109 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160316

FDA Product Code

• FCG: Biopsy Needle

Sterilization

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

[08056138586109]

Moist Heat or Steam Sterilization

[08056138586109]

Moist Heat or Steam Sterilization

[08056138586109]

Moist Heat or Steam Sterilization

[08056138586109]

Moist Heat or Steam Sterilization

[08056138586109]

Moist Heat or Steam Sterilization

[08056138586109]

Moist Heat or Steam Sterilization

[08056138586109]

Moist Heat or Steam Sterilization

[08056138586109]

Moist Heat or Steam Sterilization

[08056138586109]

Moist Heat or Steam Sterilization

[08056138586109]

Moist Heat or Steam Sterilization

[08056138586109]

Moist Heat or Steam Sterilization

[08056138586109]

Moist Heat or Steam Sterilization

[08056138586109]

Moist Heat or Steam Sterilization

[08056138586109]

Moist Heat or Steam Sterilization

[08056138586109]

Moist Heat or Steam Sterilization

[08056138586109]

Moist Heat or Steam Sterilization

[08056138586109]

Moist Heat or Steam Sterilization

[08056138586109]

Moist Heat or Steam Sterilization

[08056138586109]

Moist Heat or Steam Sterilization

[08056138586109]

Moist Heat or Steam Sterilization

[08056138586109]

Moist Heat or Steam Sterilization

[08056138586109]

Moist Heat or Steam Sterilization

[08056138586109]

Moist Heat or Steam Sterilization

[08056138586109]

Moist Heat or Steam Sterilization

[08056138586109]

Moist Heat or Steam Sterilization

[08056138586109]

Moist Heat or Steam Sterilization

[08056138586109]

Moist Heat or Steam Sterilization

[08056138586109]

Moist Heat or Steam Sterilization

[08056138586109]

Moist Heat or Steam Sterilization

[08056138586109]

Moist Heat or Steam Sterilization

[08056138586109]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-25
• Device Publish Date: 2021-05-17

On-Brand Devices [Palium]

• 08052440107018: AUTOMATIC REUSABLE GUN FOR SOFT TISSUES BIOPSY, PALIUM TYPE
• 08056138586109: REUSABLE AUTOMATIC BIOPSY INSTRUMENT