Themy TY1810

GUDID 28056138586721

DISPOSABLE AUTOMATIC DEVICE 18G X 100 mm FOR SOFT TISSUE BIOPSY, NOTCH OF 20 mm

M.D.L. S.R.L.

End-cut biopsy gun handpiece/needle

• Primary Device ID: 28056138586721
• NIH Device Record Key: 0a91d6f3-01a8-4ce7-8e6a-d3da11afe5ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Themy
• Version Model Number: TY1810
• Catalog Number: TY1810
• Company DUNS: 447228586
• Company Name: M.D.L. S.R.L.
• 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: 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

• Needle Gauge: 18 Gauge
• Length: 100 Millimeter
• Needle Gauge: 18 Gauge
• Length: 100 Millimeter
• Needle Gauge: 18 Gauge
• Length: 100 Millimeter
• Needle Gauge: 18 Gauge
• Length: 100 Millimeter
• Needle Gauge: 18 Gauge
• Length: 100 Millimeter
• Needle Gauge: 18 Gauge
• Length: 100 Millimeter
• Needle Gauge: 18 Gauge
• Length: 100 Millimeter
• Needle Gauge: 18 Gauge
• Length: 100 Millimeter
• Needle Gauge: 18 Gauge
• Length: 100 Millimeter
• Needle Gauge: 18 Gauge
• Length: 100 Millimeter
• Needle Gauge: 18 Gauge
• Length: 100 Millimeter
• Needle Gauge: 18 Gauge
• Length: 100 Millimeter
• Needle Gauge: 18 Gauge
• Length: 100 Millimeter
• Needle Gauge: 18 Gauge
• Length: 100 Millimeter
• Needle Gauge: 18 Gauge
• Length: 100 Millimeter
• Needle Gauge: 18 Gauge
• Length: 100 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08056138586727 [Primary]
GS1	28056138586721 [Package]; Contains: 08056138586727; 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: 2021-06-01
• Device Publish Date: 2021-05-24

Devices Manufactured by M.D.L. S.R.L.

• 08057276004814 - Cell-HarvestOR: 2025-05-07 MULTIRADIAL SELECTIVE HARVESTING SYSTEM OF AUTOLOGOUS BONE MARROW 11G x 100 mm
• 08057276004821 - Bone-HarvestOR: 2025-05-07 AUTOLOGOUS BONE HARVESTING SYSTEM 08G x 100 mm
• 08056138586338 - MarkX: 2025-03-10 NON-REPOSITIONAL DISPOSABLE NEEDLE 20G x 100 mm FOR MAMMARY NODULE LOCALIZATION, WITH DOUBLE HOOK
• 08057276004715 - MarkX: 2025-03-10 NON-REPOSITIONAL DISPOSABLE NEEDLE 20G x 150 mm FOR MAMMARY NODULE LOCALIZATION, WITH DOUBLE HOOK
• 28056138586721 - Themy: 2021-06-01DISPOSABLE AUTOMATIC DEVICE 18G X 100 mm FOR SOFT TISSUE BIOPSY, NOTCH OF 20 mm
• 28056138586721 - Themy: 2021-06-01 DISPOSABLE AUTOMATIC DEVICE 18G X 100 mm FOR SOFT TISSUE BIOPSY, NOTCH OF 20 mm