Titan SGS Standard Gastric Stapler

GUDID 00851677007164

STANDARD BARIATRICS, INC

Endoscopic manual linear cutting stapler, single-use Endoscopic manual linear cutting stapler, single-use Endoscopic manual linear cutting stapler, single-use Endoscopic manual linear cutting stapler, single-use Endoscopic manual linear cutting stapler, single-use Endoscopic manual linear cutting stapler, single-use Endoscopic manual linear cutting stapler, single-use Endoscopic manual linear cutting stapler, single-use Endoscopic manual linear cutting stapler, single-use Endoscopic manual linear cutting stapler, single-use Endoscopic manual linear cutting stapler, single-use Endoscopic manual linear cutting stapler, single-use Endoscopic manual linear cutting stapler, single-use Endoscopic manual linear cutting stapler, single-use

• Primary Device ID: 00851677007164
• NIH Device Record Key: 2a827f73-a17a-4940-8d16-dd07204b4307
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Titan SGS Standard Gastric Stapler
• Version Model Number: SGS23R
• Company DUNS: 091278068
• Company Name: STANDARD BARIATRICS, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851677007157 [Primary]
GS1	00851677007164 [Package]; Contains: 00851677007157; Package: [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210278

FDA Product Code

• GDW: Staple, Implantable

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: 2023-10-31
• Device Publish Date: 2023-10-23

On-Brand Devices [Titan SGS Standard Gastric Stapler]

• 00851677007089: SGS23R
• 00851677007133: SGS23Rb
• 00851677007164: SGS23R