miniRUMEL™ 080130

GUDID 10850200006589

miniRUMEL™ Device Each sterile pouch contains one (1) SINGLE PATIENT USE miniRUMEL™ Device.

LSI Solutions, Inc.

Ligature loop tightener Ligature loop tightener Ligature loop tightener Ligature loop tightener Ligature loop tightener Ligature loop tightener Ligature loop tightener Ligature loop tightener Ligature loop tightener Ligature loop tightener Ligature loop tightener Ligature loop tightener Ligature loop tightener Ligature loop tightener Ligature loop tightener, single-use Ligature loop tightener, single-use Ligature loop tightener, single-use Ligature loop tightener, single-use Ligature loop tightener, single-use Ligature loop tightener, single-use Ligature loop tightener, single-use Ligature loop tightener, single-use Ligature loop tightener, single-use Ligature loop tightener, single-use Ligature loop tightener, single-use Ligature loop tightener, single-use Ligature loop tightener, single-use Ligature loop tightener, single-use Ligature loop tightener, single-use Ligature loop tightener, single-use Ligature loop tightener, single-use Ligature loop tightener, single-use Ligature loop tightener, single-use Ligature loop tightener, single-use Ligature loop tightener, single-use Ligature loop tightener, single-use Ligature loop tightener, single-use Ligature loop tightener, single-use Ligature loop tightener, single-use Ligature loop tightener, single-use Ligature loop tightener, single-use Ligature loop tightener, single-use Ligature loop tightener, single-use Ligature loop tightener, single-use Ligature loop tightener, single-use Ligature loop tightener, single-use Ligature loop tightener, single-use Ligature loop tightener, single-use Ligature loop tightener, single-use Ligature loop tightener, single-use Ligature loop tightener, single-use Suture/ligature tightener, single-use Suture/ligature tightener, single-use Suture/ligature tightener, single-use Suture/ligature tightener, single-use Suture/ligature tightener, single-use Suture/ligature tightener, single-use Suture/ligature tightener, single-use Suture/ligature tightener, single-use Suture/ligature tightener, single-use Suture/ligature tightener, single-use Suture/ligature tightener, single-use Suture/ligature tightener, single-use Suture/ligature tightener, single-use Suture/ligature tightener, single-use Suture/ligature tightener, single-use Suture/ligature tightener, single-use

• Primary Device ID: 10850200006589
• NIH Device Record Key: b6f875de-bbf8-4069-8df5-4cfc8d7c1f08
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: miniRUMEL™
• Version Model Number: 080130
• Catalog Number: 080130
• Company DUNS: 603420183
• Company Name: LSI Solutions, 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com

Device Dimensions

• Device Size Text, specify: 0
• Length: 30 Inch
• Device Size Text, specify: 0
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Device Identifiers

Device Issuing Agency	Device ID
GS1	00850200006582 [Primary]
GS1	10850200006589 [Package]; Contains: 00850200006582; Package: Inner pack [12 Units]; In Commercial Distribution

FDA Product Code

• DWS: INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Sterilization

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

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

[10850200006589]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-13
• Device Publish Date: 2020-07-03

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