Endopack Kit - Simple2 Enzymatic Detergent and an Endoscopic Cleaning Pad

GUDID 10843356100317

Endopack Kit - Simple2 Enzymatic Detergent and an Endoscopic Cleaning Pad - 1 Pouch

CYGNUS MEDICAL L.L.C.

Medical device cleaning sponge/pad

• Primary Device ID: 10843356100317
• NIH Device Record Key: c15e1803-a577-448c-902b-6a7867b9fc80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endopack Kit - Simple2 Enzymatic Detergent and an Endoscopic Cleaning Pad
• Version Model Number: EP1-3G
• Company DUNS: 103169095
• Company Name: CYGNUS MEDICAL L.L.C.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843356100310 [Primary]
GS1	10843356100317 [Package]; Contains: 00843356100310; Package: [50 Units]; In Commercial Distribution
GS1	20843356100314 [Package]; Contains: 00843356100310; Package: [100 Units]; In Commercial Distribution

FDA Product Code

• MNL: Accessories, Cleaning Brushes, For Endoscope

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-02
• Device Publish Date: 2020-09-24

On-Brand Devices [Endopack Kit - Simple2 Enzymatic Detergent and an Endoscopic Cleaning Pad]

• 10843356100324: Endopack Kit - Simple2 Enzymatic Detergent and an Endoscopic Cleaning Pad - 1 Pouch
• 10843356100317: Endopack Kit - Simple2 Enzymatic Detergent and an Endoscopic Cleaning Pad - 1 Pouch