OPER LAP 10mm 0 AUTOCLAVE

GUDID 00821925007246

Gyrus Acmi, Inc.

Rigid optical laparoscope

• Primary Device ID: 00821925007246
• NIH Device Record Key: cf04ee5c-39e6-4b1c-b9a5-54a26b744c9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPER LAP 10mm 0 AUTOCLAVE
• Version Model Number: OL10-0A
• Company DUNS: 007198742
• Company Name: Gyrus Acmi, Inc.
• Device Count: 1
• DM Exempt: false
• 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: false
• Expiration Date: true
• 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	00821925007246 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K945266

FDA Product Code

• GCJ: Laparoscope, general & plastic surgery

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: 2016-10-05

Devices Manufactured by Gyrus Acmi, Inc.

• 00821925002074 - USA Elite System: 2024-08-02 USA Elite System Continuous Flow Resectoscope Outer Sheath, Raised Tip 25.6 Fr, (8.5 mm) Color Coded Yellow
• 00821925002098 - USA Elite System: 2024-08-02 USA Elite System Continuous Flow Resectoscope Outer Sheath, Round Tip 25.6 Fr, (8.5 mm) Color Coded Yellow
• 00821925002111 - USA Elite System: 2024-08-02 USA Elite System Rotating Continuous Flow Resectoscope Inner Sheath 25.6 Fr, (8.5 mm) Color Coded Gold
• 00821925002128 - USA Elite System: 2024-08-02 USA Elite System Rotating Continuous Flow Resectoscope Inner Sheath 27.6 Fr, (9.2 mm) Color Coded Gray
• 00821925002159 - USA Elite System: 2024-08-02 USA Elite System Resectoscope Laser Bridge
• 00821925002166 - USA Elite System: 2024-08-02 USA Elite System Continuous Flow Resectoscope Outer Sheath 25.6 Fr, (8.5 mm) Color Coded Gold
• 00821925002173 - USA Elite System: 2024-08-02 USA Elite System Continuous Flow Resectoscope Outer Sheath 27.6 Fr, (9.2 mm) Color Coded Gray
• 00821925002586 - Gyrus ACMI: 2024-08-02 Ellik Evacuator Includes Glass Body, Male Connector Tubing, and Latex Bulb