USA Elite System™ Endoscopic Injection Needle

GUDID 00821925001299

EAWE-N Reusable Injection Needle

Gyrus Acmi, Inc.

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• Primary Device ID: 00821925001299
• NIH Device Record Key: 752870b9-f10d-4b18-839a-39ef0d4a9f73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: USA Elite System™ Endoscopic Injection Needle
• Version Model Number: EAWE-N
• 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	00821925001299 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K914496

FDA Product Code

• FBK: endoscopic injection needle, gastroenterology-urology

Sterilization

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

[00821925001299]

Moist Heat or Steam Sterilization

[00821925001299]

Moist Heat or Steam Sterilization

[00821925001299]

Moist Heat or Steam Sterilization

[00821925001299]

Moist Heat or Steam Sterilization

[00821925001299]

Moist Heat or Steam Sterilization

[00821925001299]

Moist Heat or Steam Sterilization

[00821925001299]

Moist Heat or Steam Sterilization

[00821925001299]

Moist Heat or Steam Sterilization

[00821925001299]

Moist Heat or Steam Sterilization

[00821925001299]

Moist Heat or Steam Sterilization

[00821925001299]

Moist Heat or Steam Sterilization

[00821925001299]

Moist Heat or Steam Sterilization

[00821925001299]

Moist Heat or Steam Sterilization

[00821925001299]

Moist Heat or Steam Sterilization

[00821925001299]

Moist Heat or Steam Sterilization

[00821925001299]

Moist Heat or Steam Sterilization

[00821925001299]

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: 2016-10-13

Devices Manufactured by Gyrus Acmi, Inc.

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• 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)