Isolator Strip 00860013000318

GUDID 10860013000315

Fistula Solution Corporation

Ostomy convexity insert

• Primary Device ID: 10860013000315
• NIH Device Record Key: 5b5631b9-289e-4347-a840-cf0c31d3721b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Isolator Strip
• Version Model Number: 00860013000318
• Catalog Number: 00860013000318
• 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: 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	00860013000318 [Primary]
GS1	10860013000315 [Package]; Contains: 00860013000318; Package: Case [10 Units]; In Commercial Distribution

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: 2022-08-29
• Device Publish Date: 2022-08-20

Devices Manufactured by Fistula Solution Corporation

• 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
• 10860013000315 - Isolator Strip: 2022-08-29
• 00860013000325 - Fistula Funnel: 2022-08-29