Adapter, SIE, Applied ES3850

GUDID 10815288013881

ENCISION, INC.

Surgical irrigation/aspiration handpiece, reusable

• Primary Device ID: 10815288013881
• NIH Device Record Key: c05065e9-d687-472f-951c-48d8b09cabd7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Adapter, SIE, Applied
• Version Model Number: ES3850
• Catalog Number: ES3850
• Company DUNS: 612250175
• Company Name: ENCISION, 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10815288013881 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100711

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

[10815288013881]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-04-23
• Device Publish Date: 2018-09-04

On-Brand Devices [Adapter, SIE, Applied]

• 10815288013881: ES3850
• 10815288010941: ES3810