High Transmission Autoclavable Fiberoptic Light Guide Snap On 4 mm, 7

GUDID 00821925001541

G93 HIGH TRANS LIGHT CARRIER

Gyrus Acmi, Inc.

Rigid ureteroscope Rigid ureteroscope Rigid ureteroscope Rigid ureteroscope Rigid ureteroscope Rigid ureteroscope Rigid ureteroscope Rigid ureteroscope Rigid ureteroscope Rigid ureteroscope Rigid ureteroscope Rigid ureteroscope Rigid ureteroscope Rigid ureteroscope Rigid ureteroscope Rigid ureteroscope Rigid ureteroscope Rigid ureteroscope Rigid optical ureteroscope Rigid optical ureteroscope Rigid optical ureteroscope Rigid optical ureteroscope Rigid optical ureteroscope Rigid optical ureteroscope Rigid optical ureteroscope Rigid optical ureteroscope Rigid optical ureteroscope Rigid optical ureteroscope Rigid optical ureteroscope Rigid optical ureteroscope Rigid optical ureteroscope Rigid optical ureteroscope Rigid optical ureteroscope Rigid optical ureteroscope Rigid optical ureteroscope

• Primary Device ID: 00821925001541
• NIH Device Record Key: f821c74d-59f6-4e59-a637-53b785133d77
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: High Transmission Autoclavable Fiberoptic Light Guide Snap On 4 mm, 7
• Version Model Number: G93
• 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	00821925001541 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011849

FDA Product Code

• FGB: Ureteroscope and accessories, flexible/rigid

Sterilization

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

[00821925001541]

Moist Heat or Steam Sterilization

[00821925001541]

Moist Heat or Steam Sterilization

[00821925001541]

Moist Heat or Steam Sterilization

[00821925001541]

Moist Heat or Steam Sterilization

[00821925001541]

Moist Heat or Steam Sterilization

[00821925001541]

Moist Heat or Steam Sterilization

[00821925001541]

Moist Heat or Steam Sterilization

[00821925001541]

Moist Heat or Steam Sterilization

[00821925001541]

Moist Heat or Steam Sterilization

[00821925001541]

Moist Heat or Steam Sterilization

[00821925001541]

Moist Heat or Steam Sterilization

[00821925001541]

Moist Heat or Steam Sterilization

[00821925001541]

Moist Heat or Steam Sterilization

[00821925001541]

Moist Heat or Steam Sterilization

[00821925001541]

Moist Heat or Steam Sterilization

[00821925001541]

Moist Heat or Steam Sterilization

[00821925001541]

Moist Heat or Steam Sterilization

[00821925001541]

Moist Heat or Steam Sterilization

[00821925001541]

Moist Heat or Steam Sterilization

[00821925001541]

Moist Heat or Steam Sterilization

[00821925001541]

Moist Heat or Steam Sterilization

[00821925001541]

Moist Heat or Steam Sterilization

[00821925001541]

Moist Heat or Steam Sterilization

[00821925001541]

Moist Heat or Steam Sterilization

[00821925001541]

Moist Heat or Steam Sterilization

[00821925001541]

Moist Heat or Steam Sterilization

[00821925001541]

Moist Heat or Steam Sterilization

[00821925001541]

Moist Heat or Steam Sterilization

[00821925001541]

Moist Heat or Steam Sterilization

[00821925001541]

Moist Heat or Steam Sterilization

[00821925001541]

Moist Heat or Steam Sterilization

[00821925001541]

Moist Heat or Steam Sterilization

[00821925001541]

Moist Heat or Steam Sterilization

[00821925001541]

Moist Heat or Steam Sterilization

[00821925001541]

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: 2016-10-14

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• 00810008180501 - nCare: 2023-09-25 nCare, Sgl,Direct SDI,DICOM,Rcrdg
• 00810008180921 - nCare: 2023-09-25 nCare, Dual,ELA x 2,DICOM,Rcrdg
• 00810008180952 - nCare: 2023-09-25 nCare, SNGL,DRCT SDI,DICOM
• 00810008180969 - nCare: 2023-09-25 nCare, SNGL, ELA, DICOM
• 00810008180976 - nCare: 2023-09-25 nCare, SNGL, ELA, DICOM, RCRDG
• 00821925036406 - USA Elite: 2023-07-26 ACMI USA Elite System and USA Series Knife Electrode 24 Fr (8mm)