AccessGUDID - DEVICE: Secure Catch Tissue Retrieval Pouch Medium with tail attachment (05051223008170)

GUDID

Device Identifier (DI) Information

Brand Name: Secure Catch Tissue Retrieval Pouch Medium with tail attachment
Version or Model: PS3406
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PS3406
Company Name: PURPLE SURGICAL INTERNATIONAL LIMITED

Primary DI Number: 05051223008170
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 239403863 *Terms of Use

Device Description: The Purple Surgical Secure Catch Tissue Retrieval Pouch has applications in laparoscopic procedures for the safe, convenient removal of tissue specimens such as the appendix, gallbladder, ovaries, fibroids, myomas, omentum, spleen and bowel.

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
KGY	Bag, Intestine

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 175 Millimeter
Width: 125 Millimeter
Total Volume: 350 Milliliter

Device Record Status

Public Device Record Key: cffa5bcb-009f-400e-b6b9-a6ae99101a51
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 17, 2016