SMALL applicator

GUDID B108785APSMUS00

BTL INDUSTRIES LIMITED

Multi-modality hyperthermia system Multi-modality hyperthermia system Multi-modality hyperthermia system Multi-modality hyperthermia system Multi-modality hyperthermia system Multi-modality hyperthermia system Multi-modality hyperthermia system Multi-modality hyperthermia system Multi-modality hyperthermia system Multi-modality hyperthermia system Multi-modality hyperthermia system Multi-modality hyperthermia system Multi-modality hyperthermia system Multi-modality hyperthermia system Multi-modality hyperthermia system 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