Sterile NS System

GUDID 08806390855174

Jeil Medical Corporation

Cranioplasty plate, alterable Cranioplasty plate, alterable Cranioplasty plate, alterable Cranioplasty plate, alterable Cranioplasty plate, alterable Cranioplasty plate, alterable Cranioplasty plate, alterable Cranioplasty plate, alterable Cranioplasty plate, alterable Cranioplasty plate, alterable Cranioplasty plate, alterable

• Primary Device ID: 08806390855174
• NIH Device Record Key: b55f63e3-af13-495f-925f-3be890e0b0ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterile NS System
• Version Model Number: SN16-BR-020S
• Company DUNS: 688811603
• Company Name: Jeil Medical Corporation
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806390855174 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170368

FDA Product Code

• GWO: Plate, Cranioplasty, Preformed, Alterable

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2024-05-03
• Device Publish Date: 2017-10-13

On-Brand Devices [Sterile NS System]

• 08806390855228: S16-NF-003-6
• 08806390855211: S16-NF-003-3
• 08806390855204: S16-NF-003-2
• 08806390855198: SN16-DY-006
• 08806390855181: SN16-SQ-004
• 08806390855174: SN16-BR-020S
• 08806390855167: SN16-BR-010S
• 08806390855150: SN16-ST-006
• 08806390854658: SN16-ST-102
• 08806390854641: SN16-ST-002