Olsen® 90-9523-S

GUDID 00887482151969

Spatula Laparoscopic Electrode, 33CM Sterile, Single Use

SYMMETRY SURGICAL INC.

Open-surgery electrosurgical handpiece/electrode, bipolar, single-use

• Primary Device ID: 00887482151969
• NIH Device Record Key: 1660e6e0-052e-4ef0-8271-f56a1d0fc146
• Commercial Distribution Discontinuation: 9999-01-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Olsen®
• Version Model Number: 90-9523-S
• Catalog Number: 90-9523-S
• Company DUNS: 079641356
• Company Name: SYMMETRY SURGICAL INC.
• Device Count: 10
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, clean and safe place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, clean and safe place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, clean and safe place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, clean and safe place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, clean and safe place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, clean and safe place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, clean and safe place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, clean and safe place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, clean and safe place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, clean and safe place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, clean and safe place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, clean and safe place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887482122126 [Unit of Use]
GS1	00887482151969 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K912611

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

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: 2016-12-14

On-Brand Devices [Olsen®]

• 00887482151976: L Hook Laparoscopic Electrode, Single Use, Sterile, Length 13 Inches
• 00887482151969: Spatula Laparoscopic Electrode, 33CM Sterile, Single Use
• 00887482151952: J-Hook Laparoscopic Electrode, 33CM, Sterile Single Use