OTELO INSTRUMENTATION OTO-IN 05 01-N

GUDID 07640178972070

RETRACTOR SCREW EXTENDER 1

SpineArt SA

Surgical retraction system, reusable

• Primary Device ID: 07640178972070
• NIH Device Record Key: d0bf349c-47e8-4059-9c49-11bb526f7d3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OTELO INSTRUMENTATION
• Version Model Number: OTO-IN 05 01-N
• Catalog Number: OTO-IN 05 01-N
• Company DUNS: 483016148
• Company Name: SpineArt SA
• 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: 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	07640178972070 [Primary]

FDA Product Code

• GAD: Retractor

Sterilization

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

[07640178972070]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-02-15
• Device Publish Date: 2019-01-15

On-Brand Devices [OTELO INSTRUMENTATION]

• 07640178982383: RETRACTOR BLADE
• 07640178982376: RETRACTOR BLADE
• 07640178982369: RETRACTOR BLADE
• 07640178982352: RETRACTOR BLADE
• 07640178982345: RETRACTOR BLADE
• 07640178982338: RETRACTOR BLADE
• 07640178982321: RETRACTOR BLADE
• 07640178982314: RETRACTOR BLADE
• 07640178982307: RETRACTOR BLADE
• 07640178982291: RETRACTOR BLADE
• 07640178982284: RETRACTOR BLADE
• 07640178981683: ANTERIOR BLADE - DOWN - 10MM - SHORT SHANK
• 07640178981676: ANTERIOR BLADE - UP - 10MM - SHORT SHANK
• 07640178981669: ANTERIOR BLADE - DOWN - 5MM - SHORT SHANK
• 07640178981652: ANTERIOR BLADE - UP - 5MM - SHORT SHANK
• 07640178973800: RETRACTOR BLADE
• 07640178973794: RETRACTOR BLADE
• 07640178973787: RETRACTOR BLADE
• 07640178973770: RETRACTOR BLADE
• 07640178973763: RETRACTOR BLADE
• 07640178973749: RETRACTOR NUT LEFT
• 07640178973060: CONDUCTIVE DILATOR 2
• 07640178973053: CONDUCTIVE DILATOR 1
• 07640178973022: Dilator Forceps
• 07640178973015: Arm Attachment Carbon Retractor
• 07640178973008: Retractor
• 07640178972995: Anterior Blade, Down
• 07640178972988: Anterior Blade, Up
• 07640178972971: 4th Blade Assembly
• 07640178972964: K-Wire Cap
• 07640178972957: Double Hex Handle
• 07640178972940: Lengthening Shim
• 07640178972933: Non-Conductive Dilator 2
• 07640178972926: Non-Conductive Dilator 1
• 07640178972919: Shim Pin
• 07640178972902: Posterior Shim
• 07640178972087: RETRACTOR SCREW EXTENDER 2
• 07640178972070: RETRACTOR SCREW EXTENDER 1
• 07640178972063: LOCKER 2
• 07640178972056: LOCKER 1
• 07640178972018: ARM & BASE
• 07640178972001: DUAL CABLE LIGHT
• 07640178971998: EXTENSION CORD FOR LIGHT MAT
• 07640178971981: DUAL EXTENSION CORD FOR LIGHT MAT
• 07640178971974: REUSABLE LIGHT CONNECTOR
• 07640178971967: DILATOR 2
• 07640178971950: DILATOR 1
• 07640178971943: DILATOR HOLDER
• 07640178971936: KWIRE CAP
• 07640178971929: KWIRE