OTELO MIS-Instruments OTO-IN 33 01-N

GUDID 07640178982390

DILATOR NEEDLE BLUNT

SpineArt SA

Surgical retraction system, reusable

• Primary Device ID: 07640178982390
• NIH Device Record Key: d55de8a9-762f-4949-b17f-2a455cc352b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OTELO MIS-Instruments
• Version Model Number: OTO-IN 33 01-N
• Catalog Number: OTO-IN 33 01-N
• Company DUNS: 483016148
• Company Name: SpineArt SA
• 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	07640178982390 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151104

FDA Product Code

• GAD: Retractor

Sterilization

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

[07640178982390]

Moist Heat or Steam Sterilization

[07640178982390]

Moist Heat or Steam Sterilization

[07640178982390]

Moist Heat or Steam Sterilization

[07640178982390]

Moist Heat or Steam Sterilization

[07640178982390]

Moist Heat or Steam Sterilization

[07640178982390]

Moist Heat or Steam Sterilization

[07640178982390]

Moist Heat or Steam Sterilization

[07640178982390]

Moist Heat or Steam Sterilization

[07640178982390]

Moist Heat or Steam Sterilization

[07640178982390]

Moist Heat or Steam Sterilization

[07640178982390]

Moist Heat or Steam Sterilization

[07640178982390]

Moist Heat or Steam Sterilization

[07640178982390]

Moist Heat or Steam Sterilization

[07640178982390]

Moist Heat or Steam Sterilization

[07640178982390]

Moist Heat or Steam Sterilization

[07640178982390]

Moist Heat or Steam Sterilization

[07640178982390]

Moist Heat or Steam Sterilization

[07640178982390]

Moist Heat or Steam Sterilization

[07640178982390]

Moist Heat or Steam Sterilization

[07640178982390]

Moist Heat or Steam Sterilization

[07640178982390]

Moist Heat or Steam Sterilization

[07640178982390]

Moist Heat or Steam Sterilization

[07640178982390]

Moist Heat or Steam Sterilization

[07640178982390]

Moist Heat or Steam Sterilization

[07640178982390]

Moist Heat or Steam Sterilization

[07640178982390]

Moist Heat or Steam Sterilization

[07640178982390]

Moist Heat or Steam Sterilization

[07640178982390]

Moist Heat or Steam Sterilization

[07640178982390]

Moist Heat or Steam Sterilization

[07640178982390]

Moist Heat or Steam Sterilization

[07640178982390]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-09
• Device Publish Date: 2019-04-01

On-Brand Devices [OTELO MIS-Instruments]

• 07640178982390: DILATOR NEEDLE BLUNT
• 07640178989160: INSERT
• 07640178989146: INSERT
• 07640178989139: INSERT
• 07640178989122: INSTRUMENT BOX