Symmetry Scoville 57-5811

GUDID 00887482099834

SYMMETRY SURGICAL INC.

Self-retaining surgical retractor, reusable

• Primary Device ID: 00887482099834
• NIH Device Record Key: 9b0b8552-3065-4d7d-ad82-daa201e80c2a
• Commercial Distribution Discontinuation: 9999-01-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Symmetry Scoville
• Version Model Number: 57-5811
• Catalog Number: 57-5811
• Company DUNS: 079641356
• Company Name: SYMMETRY SURGICAL INC.
• Device Count: 1
• DM Exempt: true
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887482099834 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071771

FDA Product Code

• GZT: Retractor, Self-Retaining, For Neurosurgery

Sterilization

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

[00887482099834]

Moist Heat or Steam Sterilization

[00887482099834]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

On-Brand Devices [Symmetry Scoville]

• 00887482099964: Retractor Blade, Solid
• 00887482099919: Blade, 4 Prong, 1 7/8 Inches X 2 5/8 Inches
• 00887482099902: Blade, 3 Prong, 1 Inches X 2 1/2 Inches
• 00887482099834: 57-5811
• 00887482024836: Symmetry® Spatula, Scoville Brain, Large
• 00887482016510: Scoville Hemilaminectomy Retractor, 5 Inch Spread