A.M.I.-dock TissueBag DLU Large A10 212

GUDID EAMIA102120

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

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• Primary Device ID: EAMIA102120
• NIH Device Record Key: 00e72498-fc74-4cf5-9723-d328fa866115
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: A.M.I.-dock TissueBag DLU Large
• Version Model Number: A10 212
• Catalog Number: A10 212
• 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: true
• 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	EAMIA102120 [Primary]
HIBCC	EAMIA102121 [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

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