SlimLine

GUDID 00821925002562

Semi-Rigid Scissors 5 Fr, (1.67mm), 42 CM

Gyrus Acmi, Inc.

Flexible endoscopic scissors, reusable

• Primary Device ID: 00821925002562
• NIH Device Record Key: 039d7a09-afd8-40b7-a406-061ab71e4a0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SlimLine
• Version Model Number: GYS-5
• 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: 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	00821925002562 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K890328

FDA Product Code

• HIH: Hysteroscope (And Accessories)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-01
• Device Publish Date: 2024-07-24

On-Brand Devices [SlimLine]

• 00821925010987: SlimLine Self-Dilating Autoclavable Operating Semi-Rigid Ureteroscope
• 00821925009301: SlimLine self-Dilating Autoclavable Operating Semi-Rigid Ureteroscope
• 00821925002562: Semi-Rigid Scissors 5 Fr, (1.67mm), 42 CM
• 00821925002494: Semi-Rigid Biopsy Forceps 5 Fr (1,67 mm), 42 CM
• 00821925002470: Semi-Rigid Alligator Grasping Forceps 5 Fr, (1.67mm), 42 CM