Cystoscopy Resection Storage-Sterilization Tray, Double Layer

GUDID 00821925007864

ST-CR2 CYSTOSCOPY RESECTION TRAY - DO UB

Gyrus Acmi, Inc.

Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable

• Primary Device ID: 00821925007864
• NIH Device Record Key: a0ce5464-7f19-4e87-9338-dc057cfdee95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cystoscopy Resection Storage-Sterilization Tray, Double Layer
• Version Model Number: ST-CR2
• 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	00821925007864 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K944025

FDA Product Code

• FSM: TRAY, SURGICAL, INSTRUMENT

Sterilization

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

[00821925007864]

Moist Heat or Steam Sterilization

[00821925007864]

Moist Heat or Steam Sterilization

[00821925007864]

Moist Heat or Steam Sterilization

[00821925007864]

Moist Heat or Steam Sterilization

[00821925007864]

Moist Heat or Steam Sterilization

[00821925007864]

Moist Heat or Steam Sterilization

[00821925007864]

Moist Heat or Steam Sterilization

[00821925007864]

Moist Heat or Steam Sterilization

[00821925007864]

Moist Heat or Steam Sterilization

[00821925007864]

Moist Heat or Steam Sterilization

[00821925007864]

Moist Heat or Steam Sterilization

[00821925007864]

Moist Heat or Steam Sterilization

[00821925007864]

Moist Heat or Steam Sterilization

[00821925007864]

Moist Heat or Steam Sterilization

[00821925007864]

Moist Heat or Steam Sterilization

[00821925007864]

Moist Heat or Steam Sterilization

[00821925007864]

Moist Heat or Steam Sterilization

[00821925007864]

Moist Heat or Steam Sterilization

[00821925007864]

Moist Heat or Steam Sterilization

[00821925007864]

Moist Heat or Steam Sterilization

[00821925007864]

Moist Heat or Steam Sterilization

[00821925007864]

Moist Heat or Steam Sterilization

[00821925007864]

Moist Heat or Steam Sterilization

[00821925007864]

Moist Heat or Steam Sterilization

[00821925007864]

Moist Heat or Steam Sterilization

[00821925007864]

Moist Heat or Steam Sterilization

[00821925007864]

Moist Heat or Steam Sterilization

[00821925007864]

Moist Heat or Steam Sterilization

[00821925007864]

Moist Heat or Steam Sterilization

[00821925007864]

Moist Heat or Steam Sterilization

[00821925007864]

Moist Heat or Steam Sterilization

[00821925007864]

Moist Heat or Steam Sterilization

[00821925007864]

Moist Heat or Steam Sterilization

[00821925007864]

Moist Heat or Steam Sterilization

[00821925007864]

Moist Heat or Steam Sterilization

[00821925007864]

Moist Heat or Steam Sterilization

[00821925007864]

Moist Heat or Steam Sterilization

[00821925007864]

Moist Heat or Steam Sterilization

[00821925007864]

Moist Heat or Steam Sterilization

[00821925007864]

Moist Heat or Steam Sterilization

[00821925007864]

Moist Heat or Steam Sterilization

[00821925007864]

Moist Heat or Steam Sterilization

[00821925007864]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-09-10
• Device Publish Date: 2016-10-18

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• 00810008180921 - nCare: 2023-09-25 nCare, Dual,ELA x 2,DICOM,Rcrdg
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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)