BioSentry™ Tract Sealant System

GUDID 10848782023148

BioSentry™ Tract Sealant System

Surgical Specialties México, S. de R.L. de C.V.

Lung biopsy procedure kit

• Primary Device ID: 10848782023148
• NIH Device Record Key: c6b37d47-f7ce-4110-8ee4-c8f039d17a46
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioSentry™ Tract Sealant System
• Version Model Number: 768022019S
• Company DUNS: 812762226
• Company Name: Surgical Specialties México, S. de R.L. de C.V.
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848782023141 [Primary]
GS1	10848782023148 [Package]; Contains: 00848782023141; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN090007

FDA Product Code

• OMT: Absorbable lung biopsy plug

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-02-16

Devices Manufactured by Surgical Specialties México, S. de R.L. de C.V.

• 10848782051516 - Quill: 2025-07-21 Quill PDO,Violet,3-0,45cm,PS-1,Uni-Directional
• 00848782051786 - Onatec: 2025-06-10 Onalon, Nylon, Black, 10-0, 10cm, DRS, 2 arms
• 00848782051793 - Onatec: 2025-06-10 Onalon, Nylon, Black, 10-0, 10cm, HLZ, 1 arm
• 00848782051809 - Onatec: 2025-06-10 Onalon, Nylon, Black, 10-0, 10cm, 1 arm
• 10848782051813 - Onatec: 2025-06-10 Onasorb,PGA,Violet,10-0,10cm,DLZ,1 arm
• 10848782051820 - Onatec: 2025-06-10 Onasorb,PGA,Violet,8-0,13cm,DDS,1 arm
• 10848782051837 - Onatec: 2025-06-10 Onasorb,PGA,Violet,8-0,13cm,DRS,1 arm
• 10848782051844 - Onatec: 2025-06-10 Onasorb,PGA,Violet,9-0,13cm,DDS,1 arm