USA Elite System™ Continuous Flow Laser Cystourethroscope Inner Sheat

GUDID 00821925008977

CLB8-23 Inner Sheath/Bridge

Gyrus Acmi, Inc.

Rigid cystourethroscope Rigid cystourethroscope Endoscope sheath, reusable Endoscope sheath, reusable

• Primary Device ID: 00821925008977
• NIH Device Record Key: becf0468-9571-41bd-ac1d-3f350cf2d323
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: USA Elite System™ Continuous Flow Laser Cystourethroscope Inner Sheat
• Version Model Number: CLB8-23
• Company DUNS: 007198742
• Company Name: Gyrus Acmi, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	00821925008977 [Primary]

FDA Product Code

• FEC: OBTURATOR, FOR ENDOSCOPE
• HIH: Hysteroscope (And Accessories)

Sterilization

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

[00821925008977]

Moist Heat or Steam Sterilization

[00821925008977]

Moist Heat or Steam Sterilization

[00821925008977]

Moist Heat or Steam Sterilization

[00821925008977]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-10-13

On-Brand Devices [USA Elite System™ Continuous Flow Laser Cystourethroscope Inner Sheat]

• 00821925008984: CLB8-23SB LASER Inner Sheath Short Beak
• 00821925008977: CLB8-23 Inner Sheath/Bridge