Themy TY1610

GUDID 28052440101652

5 CS - THEMY AUTOMATIC NEEDLE 16GX100mm FOR SOFT TISSUE BIOPSY NOTCH OF 20 mm

M.D.L. SRL

End-cut biopsy gun handpiece/needle

• Primary Device ID: 28052440101652
• NIH Device Record Key: 50a670fa-fabf-4233-9e4f-33e1eac3507b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Themy
• Version Model Number: TY1610
• Catalog Number: TY1610
• Company DUNS: 447228586
• Company Name: M.D.L. 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: 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 Dimensions

• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge
• Length: 100 Millimeter
• Needle Gauge: 16 Gauge

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08052440101658 [Primary]
GS1	28052440101652 [Package]; Contains: 08052440101658; Package: [5 Units]; In Commercial Distribution

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: 2020-12-03
• Device Publish Date: 2020-11-25

Devices Manufactured by M.D.L. SRL

• 28052440101652 - Themy: 2020-12-035 CS - THEMY AUTOMATIC NEEDLE 16GX100mm FOR SOFT TISSUE BIOPSY NOTCH OF 20 mm
• 28052440101652 - Themy: 2020-12-03 5 CS - THEMY AUTOMATIC NEEDLE 16GX100mm FOR SOFT TISSUE BIOPSY NOTCH OF 20 mm
• 08052440103522 - Intro: 2019-10-07 10 CS - COAXIAL INTRODUCER NEEDLE 13G x 44mm
• 08058341212561 - Intro: 2019-10-07 10 CS - COAXIAL INTRODUCER NEEDLE 13G X 50mm
• 08058341216354 - Intro: 2019-10-07 COAXIAL INTRODUCER NEEDLE 13G X 75mm
• 08052440108978 - Intro: 2019-10-07 10 CS - COAXIAL INTRODUCER NEEDLE 15G X 95mm
• 08052440108985 - Intro: 2019-10-07 10 CS - COAXIAL INTRODUCER NEEDLE 15GX110mm
• 08052440108992 - Intro: 2019-10-07 COAXIAL INTRODUCER NEEDLE 15G X 140mm
• 08058341216682 - Intro: 2019-10-07 COAXIAL INTRODUCER NEEDLE 17G X 50mm