ScheBo Master Quick-Prep 28-Quick

GUDID 04260152082804

ScheBo r. Biotech Aktiengesellschaft

Faecal specimen collection kit IVD, clinical

• Primary Device ID: 04260152082804
• NIH Device Record Key: fd5bb2bc-80bd-4406-9712-422a56d4d877
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ScheBo Master Quick-Prep
• Version Model Number: Stool-Extraction System
• Catalog Number: 28-Quick
• Company DUNS: 326980364
• Company Name: ScheBo r. Biotech Aktiengesellschaft
• 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	04260152082804 [Primary]

FDA Product Code

• NNK: Container, Specimen Mailer And Storage, Non-Sterile

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: 2023-06-20
• Device Publish Date: 2023-06-12

Devices Manufactured by ScheBo r. Biotech Aktiengesellschaft

• 04260152082804 - ScheBo Master Quick-Prep: 2023-06-20
• 04260152082804 - ScheBo Master Quick-Prep: 2023-06-20
• 04260152080206 - ScheBo® Extraction buffer: 2020-09-07
• 04260152080701 - ScheBo® Pancreatic Elastase 1™: 2020-09-07