Mobius Elastic Retractor

GUDID 20888937003820

Large; 12-17 cm Incision Range

Coopersurgical, Inc.

Self-retaining surgical retractor, single-use

• Primary Device ID: 20888937003820
• NIH Device Record Key: 3797ea00-18ef-4aac-aed3-3471d511a110
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mobius Elastic Retractor
• Version Model Number: 900-520
• Company DUNS: 801895244
• Company Name: Coopersurgical, 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: false
• 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	00888937003826 [Primary]
GS1	20888937003820 [Package]; Contains: 00888937003826; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050256

FDA Product Code

• GAD: Retractor

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-06-07

On-Brand Devices [Mobius Elastic Retractor]

• 20888937003820: Large; 12-17 cm Incision Range
• 20888937003813: Medium-Large; 10-15 cm Incision Range
• 20888937003806: Medium; 8-14 cm Incision Range
• 20888937003790: Mini; 2-6 cm Incision Range
• 20888937003783: Small; 4-9 cm Incision Range