DV8® Retractor 11075150

GUDID 00860222000413

The DV8® Retractor Esophageal Balloon (DV8 Retractor) is a non-sterile, single-use, disposable esophageal balloon retractor. The DV8 Retractor is deployed orally and inflated inside the esophagus. The retractor gently and effectively retracts the esophagus to create a stable operating field.

Manual Surgical Sciences, L. L. C.

Intraluminal oesophageal retractor

• Primary Device ID: 00860222000413
• NIH Device Record Key: ab99ce34-2747-4478-bb7a-d5707dd43121
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DV8® Retractor
• Version Model Number: 11075150
• Catalog Number: 11075150
• Company DUNS: 117502037
• Company Name: Manual Surgical Sciences, L. L. C.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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 Dimensions

• Balloon Diameter: 11 Millimeter
• Balloon Length: 230 Millimeter
• Balloon Diameter: 11 Millimeter
• Balloon Length: 230 Millimeter
• Balloon Diameter: 11 Millimeter
• Balloon Length: 230 Millimeter
• Balloon Diameter: 11 Millimeter
• Balloon Length: 230 Millimeter
• Balloon Diameter: 11 Millimeter
• Balloon Length: 230 Millimeter
• Balloon Diameter: 11 Millimeter
• Balloon Length: 230 Millimeter
• Balloon Diameter: 11 Millimeter
• Balloon Length: 230 Millimeter
• Balloon Diameter: 11 Millimeter
• Balloon Length: 230 Millimeter
• Balloon Diameter: 11 Millimeter
• Balloon Length: 230 Millimeter
• Balloon Diameter: 11 Millimeter
• Balloon Length: 230 Millimeter
• Balloon Diameter: 11 Millimeter
• Balloon Length: 230 Millimeter
• Balloon Diameter: 11 Millimeter
• Balloon Length: 230 Millimeter
• Balloon Diameter: 11 Millimeter
• Balloon Length: 230 Millimeter
• Balloon Diameter: 11 Millimeter
• Balloon Length: 230 Millimeter
• Balloon Diameter: 11 Millimeter
• Balloon Length: 230 Millimeter
• Balloon Diameter: 11 Millimeter
• Balloon Length: 230 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860222000413 [Primary]

FDA Product Code

• GAD: Retractor

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: 2023-06-21
• Device Publish Date: 2023-06-13

On-Brand Devices [DV8® Retractor]

• 00860222000413: The DV8® Retractor Esophageal Balloon (DV8 Retractor) is a non-sterile, single-use, disposable
• 00860222000406: The DV8® Retractor Esophageal Balloon (DV8 Retractor) is a non-sterile, single-use, disposable