USA Elite System™ Visual Urethrotome Standard Obturator 22 Fr (7.3 m

GUDID 00821925003750

EVUS-22-O Visual Urethrotome STD OBT

Gyrus Acmi, Inc.

Urethrotome Urethrotome Rigid endoscope obturator Rigid endoscope obturator Rigid endoscope obturator Rigid endoscope obturator Rigid endoscope obturator Rigid endoscope obturator Rigid endoscope obturator Rigid endoscope obturator Rigid endoscope obturator Rigid endoscope obturator Rigid endoscope obturator Rigid endoscope obturator Rigid endoscope obturator

• Primary Device ID: 00821925003750
• NIH Device Record Key: da5c8c76-2e8c-4e01-ab50-41cddedd9167
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: USA Elite System™ Visual Urethrotome Standard Obturator 22 Fr (7.3 m
• Version Model Number: EVUS-22-O
• 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	00821925003750 [Primary]

FDA Product Code

• EZO: Urethrotome

Sterilization

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

[00821925003750]

Moist Heat or Steam Sterilization

[00821925003750]

Moist Heat or Steam Sterilization

[00821925003750]

Moist Heat or Steam Sterilization

[00821925003750]

Moist Heat or Steam Sterilization

[00821925003750]

Moist Heat or Steam Sterilization

[00821925003750]

Moist Heat or Steam Sterilization

[00821925003750]

Moist Heat or Steam Sterilization

[00821925003750]

Moist Heat or Steam Sterilization

[00821925003750]

Moist Heat or Steam Sterilization

[00821925003750]

Moist Heat or Steam Sterilization

[00821925003750]

Moist Heat or Steam Sterilization

[00821925003750]

Moist Heat or Steam Sterilization

[00821925003750]

Moist Heat or Steam Sterilization

[00821925003750]

Moist Heat or Steam Sterilization

[00821925003750]

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: 2016-10-14

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• 00810008180969 - nCare: 2023-09-25 nCare, SNGL, ELA, DICOM
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