USA Series™ Long Autoclavable Operative Telescope 12°, 2.7mm Diameter

GUDID 00821925008410

Gyrus Acmi, Inc.

Rigid endoscope telescope

• Primary Device ID: 00821925008410
• NIH Device Record Key: 32d90d8d-c03e-4f9f-bedf-f969137962e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: USA Series™ Long Autoclavable Operative Telescope 12°, 2.7mm Diameter
• Version Model Number: REXG27L-12A
• 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: false
• Serial Number: true
• 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	00821925008410 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K890328

FDA Product Code

• FAS: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• HIH: Hysteroscope (And Accessories)

Sterilization

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

[00821925008410]

Moist Heat or Steam Sterilization

[00821925008410]

Moist Heat or Steam Sterilization

[00821925008410]

Moist Heat or Steam Sterilization

[00821925008410]

Moist Heat or Steam Sterilization

[00821925008410]

Moist Heat or Steam Sterilization

[00821925008410]

Moist Heat or Steam Sterilization

[00821925008410]

Moist Heat or Steam Sterilization

[00821925008410]

Moist Heat or Steam Sterilization

[00821925008410]

Moist Heat or Steam Sterilization

[00821925008410]

Moist Heat or Steam Sterilization

[00821925008410]

Moist Heat or Steam Sterilization

[00821925008410]

Moist Heat or Steam Sterilization

[00821925008410]

Moist Heat or Steam Sterilization

[00821925008410]

Moist Heat or Steam Sterilization

[00821925008410]

Moist Heat or Steam Sterilization

[00821925008410]

Moist Heat or Steam Sterilization

[00821925008410]

Moist Heat or Steam Sterilization

[00821925008410]

Moist Heat or Steam Sterilization

[00821925008410]

Moist Heat or Steam Sterilization

[00821925008410]

Moist Heat or Steam Sterilization

[00821925008410]

Moist Heat or Steam Sterilization

[00821925008410]

Moist Heat or Steam Sterilization

[00821925008410]

Moist Heat or Steam Sterilization

[00821925008410]

Moist Heat or Steam Sterilization

[00821925008410]

Moist Heat or Steam Sterilization

[00821925008410]

Moist Heat or Steam Sterilization

[00821925008410]

Moist Heat or Steam Sterilization

[00821925008410]

Moist Heat or Steam Sterilization

[00821925008410]

Moist Heat or Steam Sterilization

[00821925008410]

Moist Heat or Steam Sterilization

[00821925008410]

Moist Heat or Steam Sterilization

[00821925008410]

Moist Heat or Steam Sterilization

[00821925008410]

Moist Heat or Steam Sterilization

[00821925008410]

Moist Heat or Steam Sterilization

[00821925008410]

Moist Heat or Steam Sterilization

[00821925008410]

Moist Heat or Steam Sterilization

[00821925008410]

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: 2016-10-05

On-Brand Devices [USA Series™ Long Autoclavable Operative Telescope 12°, 2.7mm Diameter]

• 00821925008915: G27L-12A SlimLine Long Tele 12Deg 2.7MM
• 00821925008410: REXG27L-12A