SHIPPING SYSTEM

GUDID 00718175001844

Shipping System, IBA

BIODEX MEDICAL SYSTEMS, INC.

Radiation shielding container, transport/transfer
Primary Device ID00718175001844
NIH Device Record Keyc402431c-5752-45c8-8f8f-67e99cfc6cd0
Commercial Distribution StatusIn Commercial Distribution
Brand NameSHIPPING SYSTEM
Version Model Number001-822
Company DUNS043833813
Company NameBIODEX MEDICAL SYSTEMS, 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
GS100718175001844 [Primary]

FDA Product Code

KPYShield, Protective, Personnel

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-08
Device Publish Date2019-03-29

On-Brand Devices [SHIPPING SYSTEM ]

00718175001875Shipping System, 50ml Vial Shield
00718175001851ACTIMAB-A Final Dose Form SHPR (Ac-225)
00718175001844Shipping System, IBA
00718175001837Shipping System, Trasis without Syringes
00718175001882SHIPPING SYSTEM, I-124 VIAL PIG

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