BERT®

Basic Information

• Brand Name: BERT®
• Primary DI: 05019829239992
• Version / Model: 24000
• Catalog Number: 24000
• Company Name: VERNACARE LIMITED
• Labeler DUNS: 212039119
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-12
• Public Version: 1
• Public Version Date: 2022-05-20
• Public Version Status: New
• Public Device Record Key: 5114f225-f0fe-491e-b481-c008a2c5a791

Device Description

BERT Endo Tissue Retrieval Bag

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GCJ	Laparoscope, general & plastic surgery	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05019829240004	GS1	Box	10	In Commercial Distribution
Primary	05019829239992	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K033842	000

Device Sizes

Type	Value	Unit	Text
Total Volume	80	Milliliter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry and keep out of sunlight
• Type: Storage Environment Temperature
• Temperature Range: 10 – 25 Degrees Celsius