TITAN Standard Power Unit

GUDID 00851677007096

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

• Primary Device ID: 00851677007096
• NIH Device Record Key: ec715e27-f593-4221-badb-d0088f06c849
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TITAN Standard Power Unit
• Version Model Number: SPU01
• Company DUNS: 091278068
• Company Name: STANDARD BARIATRICS, INC
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851677007096 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210278

FDA Product Code

• GDW: Staple, Implantable

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-26
• Device Publish Date: 2021-08-18

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• 10851677007116 - Standard Bougie Handpump: 2021-12-30
• 00851677007072 - Standard Bougie, 38Fr: 2021-08-26
• 00851677007089 - Titan SGS Standard Gastric Stapler: 2021-08-26
• 00851677007096 - TITAN Standard Power Unit: 2021-08-26
• 00851677007096 - TITAN Standard Power Unit: 2021-08-26
• 10851677007048 - Standard Trocar: 2020-05-05