Standard Clamp, Disposable SCD25-1

GUDID 00851677007003

STANDARD BARIATRICS, INC

Rigid endoscopic tissue manipulation forceps, single-use Rigid endoscopic tissue manipulation forceps, single-use

• Primary Device ID: 00851677007003
• NIH Device Record Key: 27546f43-85ad-4d5a-a5f2-4bb11550d6aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Standard Clamp, Disposable
• Version Model Number: SCD25-1
• Catalog Number: SCD25-1
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851677007003 [Primary]
GS1	00851677007010 [Package]; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181608

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-08-21
• Device Publish Date: 2017-11-07

On-Brand Devices [Standard Clamp, Disposable ]

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