miniARM® multiSTATION™ System 081214

GUDID 00850012846161

LIMA RetroSterno™ PADDLE

LSI Solutions, Inc.

Surgical retractor/retraction system blade, reusable

• Primary Device ID: 00850012846161
• NIH Device Record Key: 5d00075e-761b-4e2b-9325-e3d24b6502f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: miniARM® multiSTATION™ System
• Version Model Number: 081214
• Catalog Number: 081214
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850012846161 [Primary]

FDA Product Code

• MDM: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Sterilization

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

[00850012846161]

Moist Heat or Steam Sterilization

[00850012846161]

Moist Heat or Steam Sterilization

[00850012846161]

Moist Heat or Steam Sterilization

[00850012846161]

Moist Heat or Steam Sterilization

[00850012846161]

Moist Heat or Steam Sterilization

[00850012846161]

Moist Heat or Steam Sterilization

[00850012846161]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-11-10
• Device Publish Date: 2021-05-28

On-Brand Devices [miniARM® multiSTATION™ System]

• 00850012846185: RetroSterno™ PADDLE KIT (1 each LIMA and RIMA RetroSterno™ Paddle)
• 00850012846178: RIMA RetroSterno™ PADDLE
• 00850012846161: LIMA RetroSterno™ PADDLE
• 00850012846154: SubX™ STERNAL ASCENDER™ SYSTEM
• 00850012846147: M55™ RIGID miniARM® HOLDER
• 00850012846321: BITA RetroSterno™ Paddle