AccessGUDID - DEVICE: albert (05019829239985)

GUDID

Device Identifier (DI) Information

Brand Name: albert
Version or Model: 24001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 24001
Company Name: VERNACARE LIMITED

Primary DI Number: 05019829239985
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 212039119 *Terms of Use

Device Description: Impervious bag for the endoscopic retrieval of tissue. Volume 600 mL. Port size 12 mm.

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):	No
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 [?]
Premarket Submission Number Not Available/Not Released

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
Storage Environment Temperature: between 10 and 25 Degrees Celsius
Special Storage Condition, Specify: Keep dry and keep from sunlight

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Port size 12 mm
Total Volume: 600 Milliliter

Device Record Status

Public Device Record Key: 1389d11f-c354-47e2-8d44-6aff33ecbaee
Public Version Date: April 20, 2022
Public Version Number: 5
DI Record Publish Date: September 08, 2016