TruView™

GUDID M711LS5530

Silicone, SST

Innovasis, Inc.

Fibreoptic light cable

• Primary Device ID: M711LS5530
• NIH Device Record Key: 11e819e2-6cd8-4e6f-9b7f-7d474589def7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TruView™
• Version Model Number: LS-553
• Company DUNS: 156567492
• Company Name: Innovasis, 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: false
• Serial Number: true
• 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: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M711LS5530 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200874

FDA Product Code

• FST: Light, Surgical, Fiberoptic

Sterilization

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

[M711LS5530]

Moist Heat or Steam Sterilization

[M711LS5530]

Moist Heat or Steam Sterilization

[M711LS5530]

Moist Heat or Steam Sterilization

[M711LS5530]

Moist Heat or Steam Sterilization

[M711LS5530]

Moist Heat or Steam Sterilization

[M711LS5530]

Moist Heat or Steam Sterilization

[M711LS5530]

Moist Heat or Steam Sterilization

[M711LS5530]

Moist Heat or Steam Sterilization

[M711LS5530]

Moist Heat or Steam Sterilization

[M711LS5530]

Moist Heat or Steam Sterilization

[M711LS5530]

Moist Heat or Steam Sterilization

[M711LS5530]

Moist Heat or Steam Sterilization

[M711LS5530]

Moist Heat or Steam Sterilization

[M711LS5530]

Moist Heat or Steam Sterilization

[M711LS5530]

Moist Heat or Steam Sterilization

[M711LS5530]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-08
• Device Publish Date: 2022-03-31

Devices Manufactured by Innovasis, Inc.

• M711PC1330 - Gibralt®: 2025-02-10 POSTERIOR CERVICAL, PERSUADER ASSEMBLY, SST, Medcoat 2000
• M711PC1560 - Gibralt®: 2025-02-10 POSTERIOR CERVICAL,POLY, T10 HEX,DRIVER, SST, Medcoat 2000
• M711PC1660 - Gibralt®: 2025-02-10 POSTERIOR CERVICAL,INLINE REDUCER ASSISTANCE KNOB, SST, Medcoat 2000
• M711201160 - FixxSure: 2024-12-09 FixxSure Cross Link Hex Driver, SST, Radel
• M711LS758030 - HAtetracell™-C: 2024-12-09 Trial, 12L x 14W x 9-10H x 12°, SST
• M711LS758110 - HAtetracell™-C: 2024-12-09 Trial, 13L x 15W x 9-10H x 12°, SST
• M711LS758120 - HAtetracell™-C: 2024-12-09 Trial, 13L x 15W x 11-12H x 12°, SST
• M711LS758180 - HAtetracell™-C: 2024-12-09 Trial, 14L x 17W x 11-12H x 12°, SST