AccessGUDID - DEVICE: ESPINER TISSUE RETRIEVAL SYSTEM (05060358121937)

GUDID

Device Identifier (DI) Information

Brand Name: ESPINER TISSUE RETRIEVAL SYSTEM
Version or Model: EMP200ECO-US
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: ESPINER MEDICAL LIMITED

Primary DI Number: 05060358121937
Issuing Agency: GS1
Commercial Distribution End Date: July 08, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 774603880 *Terms of Use

Device Description: Laparoscopic tissue retrieval sac for use with minimally invasive procedures

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":	Yes
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 [?]
K111845	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
Total Volume: 2500 Milliliter

Device Record Status

Public Device Record Key: aa3f8df6-9613-4513-b293-52f2efaa9c3c
Public Version Date: June 10, 2024
Public Version Number: 6
DI Record Publish Date: September 23, 2016