A.M.I. TissueBag Premium TBI1011

GUDID EAMITBI10110

Mag for retrieving speciment for 10 mm trocars. 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.fsing.

AMI Agency for Medical Innovations GmbH

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• Primary Device ID: EAMITBI10110
• NIH Device Record Key: b5e253ac-6069-4a48-bbb3-a83b63fff14a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: A.M.I. TissueBag Premium
• Version Model Number: TBI1011
• Catalog Number: TBI1011
• 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: 515 Millimeter
• Length: 515 Millimeter
• Length: 515 Millimeter
• Length: 515 Millimeter
• Length: 515 Millimeter
• Length: 515 Millimeter
• Length: 515 Millimeter
• Length: 515 Millimeter
• Length: 515 Millimeter
• Length: 515 Millimeter
• Length: 515 Millimeter
• Length: 515 Millimeter
• Length: 515 Millimeter
• Length: 515 Millimeter
• Length: 515 Millimeter
• Length: 515 Millimeter
• Length: 515 Millimeter
• Length: 515 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EAMITBI10110 [Primary]
HIBCC	EAMITBI10111 [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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