Themy TY1820

GUDID 28056138586752

DISPOSABLE AUTOMATIC DEVICE 18G X 200 mm FOR SOFT TISSUE BIOPSY, NOTCH OF 20 mm

MDL SRL

End-cut biopsy gun handpiece/needle

• Primary Device ID: 28056138586752
• NIH Device Record Key: ee56804b-4a03-4063-ba5b-2586cb352954
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Themy
• Version Model Number: TY1820
• Catalog Number: TY1820
• 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: 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: 200 Millimeter
• Needle Gauge: 18 Gauge
• Length: 200 Millimeter
• Needle Gauge: 18 Gauge
• Length: 200 Millimeter
• Needle Gauge: 18 Gauge
• Length: 200 Millimeter
• Needle Gauge: 18 Gauge
• Length: 200 Millimeter
• Needle Gauge: 18 Gauge
• Length: 200 Millimeter
• Needle Gauge: 18 Gauge
• Length: 200 Millimeter
• Needle Gauge: 18 Gauge
• Length: 200 Millimeter
• Needle Gauge: 18 Gauge
• Length: 200 Millimeter
• Needle Gauge: 18 Gauge
• Length: 200 Millimeter
• Needle Gauge: 18 Gauge
• Length: 200 Millimeter
• Needle Gauge: 18 Gauge
• Length: 200 Millimeter
• Needle Gauge: 18 Gauge
• Length: 200 Millimeter
• Needle Gauge: 18 Gauge
• Length: 200 Millimeter
• Needle Gauge: 18 Gauge
• Length: 200 Millimeter
• Needle Gauge: 18 Gauge
• Length: 200 Millimeter
• Needle Gauge: 18 Gauge
• Length: 200 Millimeter
• Needle Gauge: 18 Gauge
• Length: 200 Millimeter
• Needle Gauge: 18 Gauge
• Length: 200 Millimeter
• Needle Gauge: 18 Gauge
• Length: 200 Millimeter
• Needle Gauge: 18 Gauge
• Length: 200 Millimeter
• Needle Gauge: 18 Gauge
• Length: 200 Millimeter
• Needle Gauge: 18 Gauge
• Length: 200 Millimeter
• Needle Gauge: 18 Gauge
• Length: 200 Millimeter
• Needle Gauge: 18 Gauge
• Length: 200 Millimeter
• Needle Gauge: 18 Gauge
• Length: 200 Millimeter
• Needle Gauge: 18 Gauge
• Length: 200 Millimeter
• Needle Gauge: 18 Gauge
• Length: 200 Millimeter
• Needle Gauge: 18 Gauge
• Length: 200 Millimeter
• Needle Gauge: 18 Gauge
• Length: 200 Millimeter
• Needle Gauge: 18 Gauge
• Length: 200 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08056138586758 [Primary]
GS1	28056138586752 [Package]; Contains: 08056138586758; 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: 2021-05-25
• Device Publish Date: 2021-05-17

On-Brand Devices [Themy]

• 08052440102259: THEMY AUTOMATIC NEEDLE 20Gx200mm NOTCH 20mm, WITH COAXIAL NEEDLE FOR SOFT TISSUE BIOPSY
• 08052440109067: 5 CS - THEMY AUTOMATIC NEEDLE 14Gx100mm FOR SOFT TISSUE BIOPSY NOTCH OF 20 mm
• 08052440102280: 5 CS- THEMY AUTOMATIC NEEDLE 20Gx160mm FOR SOFT TISSUE BIOPSY NOTCH OF 20 mm WITH COAXIAL
• 08052440102822: 5 CS- THEMY AUTOMATIC NEEDLE 20Gx100mm FOR SOFT TISSUE BIOPSY NOTCH OF 20 mm WITH COAXIAL
• 08052440100491: 5 CS- THEMY AUTOMATIC NEEDLE 20Gx200mm FOR SOFT TISSUE BIOPSY NOTCH OF 20 mm
• 08052440100477: 5 CS- THEMY AUTOMATIC NEEDLE 20Gx160mm FOR SOFT TISSUE BIOPSY NOTCH OF 20 mm
• 08052440100439: 5 CS- THEMY AUTOMATIC NEEDLE 20Gx100mm FOR SOFT TISSUE BIOPSY NOTCH OF 20 mm.
• 08052440100408: THEMY AUTOMATIC NEEDLE 18Gx300mm FOR SOFT TISSUE BIOPSY NOTCH OF 20mm
• 08052440100392: 5 CS- THEMY AUTOMATIC NEEDLE 18Gx250mm FOR SOFT TISSUE BIOPSY NOTCH OF 20 mm
• 08052440100378: 5 CS- THEMY AUTOMATIC NEEDLE 18Gx120mm FOR SOFT TISSUE BIOPSY NOTCH OF 20 mm
• 08052440102242: 5 CS- THEMY AUTOMATIC NEEDLE 18Gx160mm FOR SOFT TISSUE BIOPSY NOTCH OF 20 mm WITH COAXIAL
• 08058341210864: 5 CS - THEMY AUTOMATIC NEEDLE 18Gx120mm, WITH COAXIAL NEEDLE NOTCH 20mm FOR SOFT TISSUE BIOPSY
• 08058341211694: 5 CF - THEMY AUTOMATIC NEEDLE 14Gx160mm NOTCH 20mm, WITH COAXIAL NEEDLE FOR SOFT TISSUE BIOPSY
• 08058341219256: CS 5-THEMY AUTOMATIC NEEDLE 14Gx120mm NOTCH 20mm WITH COAXIAL NEEDLE FOR SOFT TISSUE BIOPSY
• 08058341210307: THEMY AUTOMATIC NEEDLE 18Gx250mm NOTCH 20mm, WITH COAXIAL NEEDLE FOR SOFT TISSUE BIOPSY OF 5 P
• 08052440101351: THEMY AUTOMATIC NEEDLE 18Gx200mm NOTCH 20mm, WITH COAXIAL NEEDLE FOR SOFT TISSUE BIOPSY OF 5 P
• 08052440109784: THEMY AUTOMATIC NEEDLE 18Gx100mm NOTCH 20mm, WITH COAXIAL NEEDLE FOR SOFT TISSUE BIOPSY
• 08052440109142: 5 CS- THEMY AUTOMATIC NEEDLE 18Gx160mm FOR SOFT TISSUE BIOPSY NOTCH OF 20 mm
• 08052440109135: THEMY AUTOMATIC NEEDLE 18G x 100mm FOR SOFT TISSUE BIOPSY NOTCH OF 20mm
• 08052440109128: 5 CS- THEMY AUTOMATIC NEEDLE 16Gx200mm FOR SOFT TISSUE BIOPSY NOTCH OF 20 mm
• 08052440109111: 5 CS- THEMY AUTOMATIC NEEDLE 16Gx160mm FOR SOFT TISSUE BIOPSY NOTCH OF 20 mm
• 08052440109791: 5 CS- THEMY AUTOMATIC NEEDLE 14Gx100mm FOR SOFT TISSUE BIOPSY NOTCH OF 20 mm WITH COAXIAL
• 08052440109098: THEMY AUTOMATIC NEEDLE 14G x 200mm FOR SOFT TISSUE BIOPSY NOTCH OF 20mm
• 08052440109081: 5 CS - THEMY AUTOMATIC NEEDLE 14Gx160mm FOR SOFT TISSUE BIOPSY NOTCH OF 20 mm
• 08052440109074: 5 CS- THEMY AUTOMATIC NEEDLE 14Gx120mm FOR SOFT TISSUE BIOPSY NOTCH OF 20 mm
• 08052440109159: 5 CS- THEMY AUTOMATIC NEEDLE 18Gx200mm FOR SOFT TISSUE BIOPSY NOTCH OF 20 mm
• 08052440109104: 5 CS- THEMY AUTOMATIC NEEDLE 16Gx100mm FOR SOFT TISSUE BIOPSY NOTCH OF 20 mm
• 08058341217634: DISPOSABLE AUTOMATIC DEVICE 12G X 60 mm FOR SOFT TISSUE BIOPSY, NOTCH OF 20 mm
• 08058341217061: DISPOSABLE AUTOMATIC DEVICE 12G X 90 mm FOR SOFT TISSUE BIOPSY, NOTCH OF 20 mm
• 08058341217054: DISPOSABLE AUTOMATIC DEVICE 12G X 110 mm FOR SOFT TISSUE BIOPSY, NOTCH OF 20 mm
• 08052440100347: DISPOSABLE AUTOMATIC DEVICE 16G X 120 mm FOR SOFT TISSUE BIOPSY, NOTCH OF 20 mm
• 28056138586912: DISPOSABLE AUTOMATIC DEVICE 20G X 200 mm FOR SOFT TISSUE BIOPSY, NOTCH OF 20 mm, WITH COAXIAL
• 28056138586905: DISPOSABLE AUTOMATIC DEVICE 20G X 160 mm FOR SOFT TISSUE BIOPSY, NOTCH OF 20 mm, WITH COAXIAL
• 28056138586899: DISPOSABLE AUTOMATIC DEVICE 20G X 100 mm FOR SOFT TISSUE BIOPSY, NOTCH OF 20 mm, WITH COAXIAL
• 28056138586882: DISPOSABLE AUTOMATIC DEVICE 18G X 250 mm FOR SOFT TISSUE BIOPSY, NOTCH OF 20 mm, WITH COAXIAL
• 28056138586875: DISPOSABLE AUTOMATIC DEVICE 18G X 200 mm FOR SOFT TISSUE BIOPSY, NOTCH OF 20 mm, WITH COAXIAL
• 28056138586868: DISPOSABLE AUTOMATIC DEVICE 18G X 160 mm FOR SOFT TISSUE BIOPSY, NOTCH OF 20 mm, WITH COAXIAL
• 28056138586851: DISPOSABLE AUTOMATIC DEVICE 18G X 120 mm FOR SOFT TISSUE BIOPSY, NOTCH OF 20 mm, WITH COAXIAL
• 28056138586844: DISPOSABLE AUTOMATIC DEVICE 18G X 100 mm FOR SOFT TISSUE BIOPSY, NOTCH OF 20 mm, WITH COAXIAL
• 28056138586837: DISPOSABLE AUTOMATIC DEVICE 14G X 160 mm FOR SOFT TISSUE BIOPSY, NOTCH OF 20 mm, WITH COAXIAL
• 28056138586820: DISPOSABLE AUTOMATIC DEVICE 14G X 120 mm FOR SOFT TISSUE BIOPSY, NOTCH OF 20 mm, WITH COAXIAL
• 28056138586813: DISPOSABLE AUTOMATIC DEVICE 14G X 100 mm FOR SOFT TISSUE BIOPSY, NOTCH OF 20 mm, WITH COAXIAL
• 28056138586806: DISPOSABLE AUTOMATIC DEVICE 20G X 200 mm FOR SOFT TISSUE BIOPSY, NOTCH OF 20 mm
• 28056138586790: DISPOSABLE AUTOMATIC DEVICE 20G X 160 mm FOR SOFT TISSUE BIOPSY, NOTCH OF 20 mm
• 08056138586789: DISPOSABLE AUTOMATIC DEVICE 20G X 100 mm FOR SOFT TISSUE BIOPSY, NOTCH OF 20 mm
• 28056138586776: DISPOSABLE AUTOMATIC DEVICE 18G X 300 mm FOR SOFT TISSUE BIOPSY, NOTCH OF 20 mm
• 28056138586769: DISPOSABLE AUTOMATIC DEVICE 18G X 250 mm FOR SOFT TISSUE BIOPSY, NOTCH OF 20 mm
• 28056138586752: DISPOSABLE AUTOMATIC DEVICE 18G X 200 mm FOR SOFT TISSUE BIOPSY, NOTCH OF 20 mm
• 28056138586745: DISPOSABLE AUTOMATIC DEVICE 18G X 160 mm FOR SOFT TISSUE BIOPSY, NOTCH OF 20 mm
• 28056138586738: DISPOSABLE AUTOMATIC DEVICE 18G X 120 mm FOR SOFT TISSUE BIOPSY, NOTCH OF 20 mm