Standard Bougie Handpump

GUDID 10851677007116

STANDARD BARIATRICS, INC

Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile

• Primary Device ID: 10851677007116
• NIH Device Record Key: 338b5d9f-d03b-4de0-af61-bb35cf8d98af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Standard Bougie Handpump
• Version Model Number: SBHP
• Company DUNS: 091278068
• Company Name: STANDARD BARIATRICS, INC
• Device Count: 1
• DM Exempt: false
• 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: false
• 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	00851677007119 [Primary]
GS1	10851677007116 [Package]; Contains: 00851677007119; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212728

FDA Product Code

• KNT: Tubes, Gastrointestinal (And Accessories)

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: 2021-12-30
• Device Publish Date: 2021-12-22

Devices Manufactured by STANDARD BARIATRICS, INC

• 00851677007164 - Titan SGS Standard Gastric Stapler: 2023-10-31
• 10851677007123 - Standard Tapered Bougie, 38Fr: 2022-12-06
• 00851677007133 - Titan SGS Standard Gastric Stapler: 2022-06-10
• 10851677007116 - Standard Bougie Handpump: 2021-12-30
• 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
• 10851677007048 - Standard Trocar: 2020-05-05