Symmetry Jannetta 57-9028

GUDID 00887482100578

Retractor Blade, Malleable, 15.0 Wide mm X 70.0 mm Deep

SYMMETRY SURGICAL INC.

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

• Primary Device ID: 00887482100578
• NIH Device Record Key: a2d8e137-f417-4093-9864-bb0818b9c878
• Commercial Distribution Discontinuation: 9999-01-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Symmetry Jannetta
• Version Model Number: 57-9028
• Catalog Number: 57-9028
• 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	00887482100578 [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

[00887482100578]

Moist Heat or Steam Sterilization

[00887482100578]

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

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• 00887482100608: Retractor Blade, Malleable, 10.0 mm Wide X 95.0 mm Deep
• 00887482100592: Retractor Blade, Malleable, 25.0 mm Wide X 75.0 mm Deep
• 00887482100585: Retractor Blade, Malleable, 20.0 mm Wide X 75.0 mm Deep
• 00887482100578: Retractor Blade, Malleable, 15.0 Wide mm X 70.0 mm Deep
• 00887482100561: Round Bar, 100.0 mm, 2 Swivels
• 00887482100554: Double Round Bar, 100.0 mm, 3 Swivels
• 00887482100547: Retractor Body, With 4 Post