Symmetry Hardy 57-3558

GUDID 00887482036006

Bivalve Specula

SYMMETRY SURGICAL INC.

Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable

• Primary Device ID: 00887482036006
• NIH Device Record Key: 4b71c002-ef32-4bd8-a740-9b442b0fd79b
• Commercial Distribution Discontinuation: 9999-01-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Symmetry Hardy
• Version Model Number: 57-3558
• Catalog Number: 57-3558
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887482036006 [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

[00887482036006]

Moist Heat or Steam Sterilization

[00887482036006]

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: 2016-09-21

On-Brand Devices [Symmetry Hardy]

• 00887482096000: Bi-Valve Speculum 13.0 X 70.0 mm Blades
• 00887482092996: Sella Punch 40º Down 2.0MM
• 00887482036006: Bivalve Specula
• 00887482035993: Bi-Valve Speculum 13.0 X 90.0 mm Blades