BERT® 24003DS

GUDID 05019829240073

NUBERT DS New Bag for Endoscopic Retrieval of Tissue (US only)

VERNACARE LIMITED

Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag

• Primary Device ID: 05019829240073
• NIH Device Record Key: 8eaafdd2-5a24-4d15-808b-1fc2dc97a9df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BERT®
• Version Model Number: 24003DS
• Catalog Number: 24003DS
• Company DUNS: 212039119
• Company Name: VERNACARE LIMITED
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4401204529494
• Email: Regulatory.Affairs@vernagroup.com
• Phone: +4401204529494
• Email: Regulatory.Affairs@vernagroup.com
• Phone: +4401204529494
• Email: Regulatory.Affairs@vernagroup.com
• Phone: +4401204529494
• Email: Regulatory.Affairs@vernagroup.com
• Phone: +4401204529494
• Email: Regulatory.Affairs@vernagroup.com
• Phone: +4401204529494
• Email: Regulatory.Affairs@vernagroup.com

Device Dimensions

• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep out of sunlight
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep out of sunlight
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep out of sunlight
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep out of sunlight
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep out of sunlight
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep out of sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	05019829239930 [Primary]
GS1	05019829240073 [Package]; Contains: 05019829239930; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033842

FDA Product Code

• GCJ: Laparoscope, general & plastic surgery

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-20
• Device Publish Date: 2022-05-12

On-Brand Devices [BERT®]

• 05019829240004: BERT Endo Tissue Retrieval Bag
• 05019829240042: NUBERT Plus New Bag for Endoscopic Retrieval of Tissue
• 05019829240073: NUBERT DS New Bag for Endoscopic Retrieval of Tissue (US only)