Proxcelan™ Cs-131 Preloaded Mick® Cartridges - Non Sterile

GUDID M748PL4NS0

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 IDM748PL4NS0
NIH Device Record Key7bc3ca3d-9689-44d4-ba6c-5bbd2d271caf
Commercial Distribution Discontinuation2024-04-19
Commercial Distribution StatusNot in Commercial Distribution
Brand NameProxcelan™ Cs-131 Preloaded Mick® Cartridges - Non Sterile
Version Model NumberPL-4NS
Company DUNS113577485
Company NameISORAY MEDICAL, INC.
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM748PL4NS0 [Primary]

FDA Product Code

KXKSource, Brachytherapy, Radionuclide

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M748PL4NS0]

Moist Heat or Steam Sterilization

[M748PL4NS0]

Moist Heat or Steam Sterilization

[M748PL4NS0]

Moist Heat or Steam Sterilization

[M748PL4NS0]

Moist Heat or Steam Sterilization

[M748PL4NS0]

Moist Heat or Steam Sterilization

[M748PL4NS0]

Moist Heat or Steam Sterilization

[M748PL4NS0]

Moist Heat or Steam Sterilization

[M748PL4NS0]

Moist Heat or Steam Sterilization

[M748PL4NS0]

Moist Heat or Steam Sterilization

[M748PL4NS0]

Moist Heat or Steam Sterilization

[M748PL4NS0]

Moist Heat or Steam Sterilization

[M748PL4NS0]

Moist Heat or Steam Sterilization

[M748PL4NS0]

Moist Heat or Steam Sterilization

[M748PL4NS0]

Moist Heat or Steam Sterilization

[M748PL4NS0]

Moist Heat or Steam Sterilization

[M748PL4NS0]

Moist Heat or Steam Sterilization

[M748PL4NS0]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-04-23
Device Publish Date2015-10-28

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 [Proxcelan]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PROXCELAN
PROXCELAN
77120303 3468807 Dead/Cancelled
IsoRay Medical, Inc.
2007-03-01
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