FocESS WCS-100

GUDID 00857326005567

HD Wireless Camera

ENTELLUS MEDICAL, INC.

Endoscope video camera

• Primary Device ID: 00857326005567
• NIH Device Record Key: d826fd3c-9c2b-4888-b4d2-c1a21e5df2c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FocESS
• Version Model Number: WCS
• Catalog Number: WCS-100
• Company DUNS: 017283879
• Company Name: ENTELLUS MEDICAL, INC.
• 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: false
• 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	00857326005567 [Primary]
GS1	10857326005564 [Package]; Package: [1 Units]; In Commercial Distribution

FDA Product Code

• FWL: Camera, Cine, Endoscopic, Without Audio

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-07-07
• Device Publish Date: 2020-09-18

Devices Manufactured by ENTELLUS MEDICAL, INC.

• 00850002250237 - TGS: 2023-07-07 Universal Headrest
• 00850002250244 - TGS: 2023-07-07 Universal Headrest Mounting Arm
• 00850002250251 - TGS: 2023-07-07 Universal Headrest Adapter A
• 00850002250268 - TGS: 2023-07-07 Universal Headrest Adapter B
• 00850002250275 - TGS: 2023-07-07 Universal Headrest Adapter C
• 00857326005567 - FocESS: 2023-07-07HD Wireless Camera
• 00857326005567 - FocESS: 2023-07-07 HD Wireless Camera
• 00857326005581 - Portable Red LED Light Source: 2023-07-07 LED light source, red
• 00857326005536 - XeroGel: 2023-07-07 Nasal Epistaxis 2 Pack