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 IDB108785APSMUS00
NIH Device Record Keyae3ba092-bf08-4ffd-b58e-501be8f02d73
Commercial Distribution StatusIn Commercial Distribution
Brand NameSMALL applicator
Version Model NumberSMALL applicator
Company DUNS733532951
Company NameBTL INDUSTRIES LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB108785APSMUS00 [Primary]

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-30
Device Publish Date2021-12-22

On-Brand Devices [SMALL applicator]

B108299AP27ENUS0100BTL-299-7
B108899AP2M2MUS00899-AP-M-2
B108899AP2C2MUS00899-AP-C-2
B108785APSMUS00SMALL applicator
B108899AP2C2MUS10899-AP-C-2
B108899AP2C2MUS20899-AP-C-2

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