Isolation Device Mixed pack 00860013000394

GUDID 00860013000394

Convenience kit containing 1 each: • REF 00860013000301 Wound Crown® • REF 00860013000325 Fistula Funnel® • REF 00860013000318 Isolator Strip®

Fistula Solution Corporation

Ostomy convexity insert Ostomy convexity insert Ostomy convexity insert Ostomy convexity insert Ostomy convexity insert Ostomy convexity insert Ostomy convexity insert Ostomy convexity insert Ostomy convexity insert Ostomy convexity insert Ostomy convexity insert Ostomy convexity insert Ostomy convexity insert Ostomy convexity insert Ostomy convexity insert Ostomy convexity insert Ostomy convexity insert Ostomy convexity insert

• Primary Device ID: 00860013000394
• NIH Device Record Key: 3d22716c-b979-42d7-b95c-8f3e3682a2f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Isolation Device Mixed pack
• Version Model Number: 00860013000394
• Catalog Number: 00860013000394
• Company DUNS: 007596766
• Company Name: Fistula Solution Corporation
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• 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	00860013000394 [Primary]

FDA Product Code

• EZS: Appliance, Colostomy, Disposable

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: 2023-12-08
• Device Publish Date: 2023-11-30

Devices Manufactured by Fistula Solution Corporation

• 00860013000394 - Isolation Device Mixed pack: 2023-12-08Convenience kit containing 1 each: • REF 00860013000301 Wound Crown® • REF 00860013000325 Fistula Funnel® • REF 00860013000318 Isolator Strip®
• 00860013000394 - Isolation Device Mixed pack: 2023-12-08 Convenience kit containing 1 each: • REF 00860013000301 Wound Crown® • REF 00860013000325 Fistula Funnel® • REF 008600
• 00860013000301 - Wound Crown: 2022-08-29
• 10860013000315 - Isolator Strip: 2022-08-29
• 00860013000325 - Fistula Funnel: 2022-08-29