Standard Clamp, Disposable

GUDID 00851677007027

STANDARD BARIATRICS, INC

Rigid endoscopic tissue manipulation forceps, single-use

• Primary Device ID: 00851677007027
• NIH Device Record Key: 86c81c0f-60df-481b-9372-4f44b8a784de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Standard Clamp, Disposable
• Version Model Number: SCD22-1
• 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: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851677007027 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190788

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: 2020-01-31
• Device Publish Date: 2020-01-23

On-Brand Devices [Standard Clamp, Disposable]

• 00851677007003: SCD25-1
• 00851677007027: SCD22-1