A.M.I.-dock TissueBag DLU A10 211

GUDID EAMIA102110

Loading unit for retrieving specimen for A.M.I.-dock Applicator 10mm. The various types of retrieval bags belonging to the A.M.I. TissueBag System are intended for safe removal of specimen (appendix, gallbladder, ovaries, fibroid tumours and other tissues, and calculi …) during laparoscopic surgery.

AMI Agency for Medical Innovations GmbH

Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag

• Primary Device ID: EAMIA102110
• NIH Device Record Key: c04976bb-76af-4a66-88e1-da9d57ae778f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: A.M.I.-dock TissueBag DLU
• Version Model Number: A10 211
• Catalog Number: A10 211
• Company DUNS: 303655286
• Company Name: AMI Agency for Medical Innovations GmbH
• Device Count: 1
• 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: 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: 180 Millimeter
• Length: 180 Millimeter
• Length: 180 Millimeter
• Length: 180 Millimeter
• Length: 180 Millimeter
• Length: 180 Millimeter
• Length: 180 Millimeter
• Length: 180 Millimeter
• Length: 180 Millimeter
• Length: 180 Millimeter
• Length: 180 Millimeter
• Length: 180 Millimeter
• Length: 180 Millimeter
• Length: 180 Millimeter
• Length: 180 Millimeter
• Length: 180 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EAMIA102110 [Primary]
HIBCC	EAMIA102111 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092821

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-04-12
• Device Publish Date: 2018-11-28

Devices Manufactured by AMI Agency for Medical Innovations GmbH

• EAMIMCS55110 - More-Cell-System: 2021-12-17 More-Cell-System is intended for use as a tissue containment system during minimally invasive gynecologic laparoscopic surgery t
• EAMIMCS55311 - More-Cell Bag: 2021-12-17 More-Cell Bag is intended for use as a tissue containment system during minimally invasive gynecologic laparoscopic surgery to e
• MCS55511 - More-Cell-System 30: 2021-12-17 More-Cell-System is intended for use as a tissue containment system during minimally invasive gynecologic laparoscopic surgeryto
• EAMIAFC1000 - A.M.I. FasciaCutter Disposable Instrument: 2020-02-06 The A.M.I. FasciaCutter Disposable Instrument is a sterile, disposable scalpel that is used to for enlargement of trocar incisio
• EAMIA054920 - A.M.I.-dock Applicator Short 5mm: 2019-04-23 Handle and instrument for A.M.I. loading units for A.M.I.-dock Applicator 5mm. The A.M.I.-dock Applicator serves as endoscopic m
• EAMIA054930 - A.M.I.-dock Applicator Curved 5mm: 2019-04-23 Handle and instrument for A.M.I. loading units for A.M.I.-dock Applicator 5mm. The A.M.I.-dock Applicator serves as endoscopic c
• EAMIA101110 - A.M.I.-dock Applicator Standard 10mm: 2019-04-23 Handle and instrument for A.M.I. loading units for A.M.I.-dock Applicator 10mm. The A.M.I.-dock Applicator serves as endoscopic
• EAMIA101120 - A.M.I.-dock Applicator Short 10mm: 2019-04-23 Handle and instrument for A.M.I. loading units for A.M.I.-dock Applicator 10mm. The A.M.I.-dock Applicator serves as endoscopic