BERT® 24000

GUDID 05019829240004

BERT Endo Tissue Retrieval Bag

VERNACARE LIMITED

Tissue extraction bag

• Primary Device ID: 05019829240004
• NIH Device Record Key: 5114f225-f0fe-491e-b481-c008a2c5a791
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BERT®
• Version Model Number: 24000
• Catalog Number: 24000
• 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: 80 Milliliter
• Total Volume: 80 Milliliter
• Total Volume: 80 Milliliter
• Total Volume: 80 Milliliter
• Total Volume: 80 Milliliter
• Total Volume: 80 Milliliter

Operating and Storage Conditions

• 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
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05019829239992 [Primary]
GS1	05019829240004 [Package]; Contains: 05019829239992; 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)