AccessGUDID - DEVICE: A.M.I.-dock TissueBag DLU Large (EAMIA102120)

GUDID

Device Identifier (DI) Information

Brand Name: A.M.I.-dock TissueBag DLU Large
Version or Model: A10 212
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: A10 212
Company Name: AMI Agency for Medical Innovations GmbH

Primary DI Number: EAMIA102120
Issuing Agency: HIBCC
Commercial Distribution End Date: December 31, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 303655286 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45130	Tissue extraction bag	An impervious, flexible, sterile container intended to be used during minimally-invasive, typically keyhole, surgical techniques (e.g., laparoscopic) to extract dissected patient body tissue. The device is inserted into the body through a large bore cannula port, and the tissue to be extracted is placed in the bag with trans-cannula instruments and evacuated through the cannula. The device typically includes an x-ray detectable thread. This device may be used for surgical interventions such as an appendectomy, colonectomy, lymphadenectomy, or gallbladder removal. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCJ	Laparoscope, General & Plastic Surgery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K092821	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 180 Millimeter

Device Record Status

Public Device Record Key: 00e72498-fc74-4cf5-9723-d328fa866115
Public Version Date: January 02, 2023
Public Version Number: 4
DI Record Publish Date: November 28, 2018