Blu Blade

GUDID M748BB10

ISORAY MEDICAL, INC.

General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual
Primary Device IDM748BB10
NIH Device Record Key6be38e79-333b-4805-b061-ce0710e9d1d8
Commercial Distribution StatusIn Commercial Distribution
Brand NameBlu Blade
Version Model NumberBB-1
Company DUNS113577485
Company NameISORAY MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM748BB10 [Primary]

FDA Product Code

IWJSystem, Applicator, Radionuclide, Manual

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M748BB10]

Moist Heat or Steam Sterilization

[M748BB10]

Moist Heat or Steam Sterilization

[M748BB10]

Moist Heat or Steam Sterilization

[M748BB10]

Moist Heat or Steam Sterilization

[M748BB10]

Moist Heat or Steam Sterilization

[M748BB10]

Moist Heat or Steam Sterilization

[M748BB10]

Moist Heat or Steam Sterilization

[M748BB10]

Moist Heat or Steam Sterilization

[M748BB10]

Moist Heat or Steam Sterilization

[M748BB10]

Moist Heat or Steam Sterilization

[M748BB10]

Moist Heat or Steam Sterilization

[M748BB10]

Moist Heat or Steam Sterilization

[M748BB10]

Moist Heat or Steam Sterilization

[M748BB10]

Moist Heat or Steam Sterilization

[M748BB10]

Moist Heat or Steam Sterilization

[M748BB10]

Moist Heat or Steam Sterilization

[M748BB10]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-05
Device Publish Date2019-03-28

Devices Manufactured by ISORAY MEDICAL, INC.

M748BBC10 - Blu Build Spacer Cartridge2024-04-23
M748BBL10 - Blu Build Real Time Loader Device2024-04-23
M748BBS10 - Blu Build Sleeve Carrier2024-04-23
M748CS10 - Proxcelan™ Cs-131 Brachytherapy Seeds 2024-04-23
M748CS1NS0 - Proxcelan™ Cs-131 Brachytherapy Seeds 2024-04-23
M748PL10 - Proxcelan™ Cs-131 Strands2024-04-23
M748PL20 - Proxcelan™ Cs-131 Preloaded Strands in 18G Needles2024-04-23
M748PL30 - Proxcelan™ Cs-131 Preloaded 18G Needles2024-04-23

Trademark Results [Blu Blade]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BLU BLADE
BLU BLADE
88674521 not registered Live/Pending
Isoray Medical, Inc.
2019-10-30
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.