SMALL applicator

GUDID B108785APSMUS00

BTL INDUSTRIES LIMITED

Multi-modality hyperthermia system

• Primary Device ID: B108785APSMUS00
• NIH Device Record Key: ae3ba092-bf08-4ffd-b58e-501be8f02d73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMALL applicator
• Version Model Number: SMALL applicator
• Company DUNS: 733532951
• Company Name: BTL INDUSTRIES LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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
HIBCC	B108785APSMUS00 [Primary]

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

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: 2021-12-30
• Device Publish Date: 2021-12-22

On-Brand Devices [SMALL applicator]

• B108299AP27ENUS0100: BTL-299-7
• B108899AP2M2MUS00: 899-AP-M-2
• B108899AP2C2MUS00: 899-AP-C-2
• B108785APSMUS00: SMALL applicator
• B108899AP2C2MUS10: 899-AP-C-2
• B108899AP2C2MUS20: 899-AP-C-2