Sterile NS System

GUDID 08806390854641

Jeil Medical Corporation

Cranioplasty plate, alterable

• Primary Device ID: 08806390854641
• NIH Device Record Key: fead6fca-0547-44a4-87d9-a3706ad9abd3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterile NS System
• Version Model Number: SN16-ST-002
• 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	08806390854641 [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: 2017-09-20

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