transP - Perine Adaptater

GUDID 03665134000202

PERINE range guides are made up of one part fixed on the ultrasound probe, which enables needle guiding. PERINE range guides guide needles of 14 to 20 gauges. The guiding aims to place the needle in the ultrasound image plane. The guides are reusable medical devices.

KOELIS

Nonimplantable needle guide, reusable

• Primary Device ID: 03665134000202
• NIH Device Record Key: d1342800-49da-4000-af21-a971d5cce915
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: transP - Perine Adaptater
• Version Model Number: KRGA.EL5
• Company DUNS: 290318455
• Company Name: KOELIS
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	03665134000202 [Unit of Use]
GS1	03665134000271 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171040

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

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

[03665134000202]

Moist Heat or Steam Sterilization

[03665134000202]

Moist Heat or Steam Sterilization

[03665134000202]

Moist Heat or Steam Sterilization

[03665134000202]

Moist Heat or Steam Sterilization

[03665134000202]

Moist Heat or Steam Sterilization

[03665134000202]

Moist Heat or Steam Sterilization

[03665134000202]

Moist Heat or Steam Sterilization

[03665134000202]

Moist Heat or Steam Sterilization

[03665134000202]

Moist Heat or Steam Sterilization

[03665134000202]

Moist Heat or Steam Sterilization

[03665134000202]

Moist Heat or Steam Sterilization

[03665134000202]

Moist Heat or Steam Sterilization

[03665134000202]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-27
• Device Publish Date: 2020-07-17

Devices Manufactured by KOELIS

• 03665134000851 - 3D Side Fire Endocavity Probe: 2024-08-07
• 03665134000936 - Steady Pro: 2024-06-11 Probe holder for transperineal approach. The Steady Pro range is intended to reliably maintain the position of a transrectal ult
• 03665134000929 - MrDraw: 2023-10-10 A system based on the PROMAP – 3D Prostate Suite range intended to define prostate contour and targets the region of interest
• 03665134000509 - 3D End-Fire Endocavity Probe: 2023-04-13 Invasive 2D/3D endocavity probe (linear) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam, 3
• 03665134000516 - 3D Side-Fire Endocavity Probe: 2023-04-13 Invasive 2D/3D endocavity probe (linear) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam, 3
• 03665134000523 - 2D Abdominal Probe: 2023-04-13 Surface 2D probe (Convex) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam for Abdominal, Gy
• 03665134000530 - 2D Linear Probe: 2023-04-13 Surface 2D probe (linear) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam for Abdominal, Gy
• 03665134000189 - CON LEAD 14G: 2023-04-13 Needle guide compatible with the abdominal 2D ultrasound probe. It is made of two parts. One part is fixed on the ultrasound pro