Symmetry Selverstone 57-1254

GUDID 00887482094334

IVD Rongeur

SYMMETRY SURGICAL INC.

Neurosurgical rongeur

• Primary Device ID: 00887482094334
• NIH Device Record Key: ea18659c-34c2-4f5e-b9f6-e74dc11479a5
• Commercial Distribution Discontinuation: 9999-01-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Symmetry Selverstone
• Version Model Number: 57-1254
• Catalog Number: 57-1254
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887482094334 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081651

FDA Product Code

• HAE: Rongeur, Manual

Sterilization

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

[00887482094334]

Moist Heat or Steam Sterilization

[00887482094334]

Moist Heat or Steam Sterilization

[00887482094334]

Moist Heat or Steam Sterilization

[00887482094334]

Moist Heat or Steam Sterilization

[00887482094334]

Moist Heat or Steam Sterilization

[00887482094334]

Moist Heat or Steam Sterilization

[00887482094334]

Moist Heat or Steam Sterilization

[00887482094334]

Moist Heat or Steam Sterilization

[00887482094334]

Moist Heat or Steam Sterilization

[00887482094334]

Moist Heat or Steam Sterilization

[00887482094334]

Moist Heat or Steam Sterilization

[00887482094334]

Moist Heat or Steam Sterilization

[00887482094334]

Moist Heat or Steam Sterilization

[00887482094334]

Moist Heat or Steam Sterilization

[00887482094334]

Moist Heat or Steam Sterilization

[00887482094334]

Moist Heat or Steam Sterilization

[00887482094334]

Moist Heat or Steam Sterilization

[00887482094334]

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: 2016-09-23

On-Brand Devices [Symmetry Selverstone]

• 00887482094341: Ivd Rongeur 2X3 mm Cup 6"
• 00887482094334: IVD Rongeur
• 00887482022436: Ivd Rongeur 2 X 5
• 00887482022429: Ivd Rongeur 2 X 3