Paxman Accessories

GUDID B561ACCESSORIES2

PAXMAN COOLERS LIMITED

Scalp cooling system
Primary Device IDB561ACCESSORIES2
NIH Device Record Key46741692-1c07-4ee8-ac94-9205d0166633
Commercial Distribution StatusIn Commercial Distribution
Brand NamePaxman Accessories
Version Model NumberAccessories Pack
Company DUNS519917264
Company NamePAXMAN COOLERS 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 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
HIBCCB561ACCESSORIES2 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PMCScalp Cooling System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-04-05

Devices Manufactured by PAXMAN COOLERS LIMITED

B561PSCSKITL251 - Paxman cap kit2022-03-28
B561PSCSKITLA251 - Paxman cap kit2022-03-28
B561PSCSKITM251 - Paxman cap kit2022-03-28
B561PSCSKITMA251 - Paxman cap kit2022-03-28
B561PSCSKITMS251 - Paxman cap kit2022-03-28
B561PSCSKITS251 - Paxman cap kit2022-03-28
B561PSCSKITSA251 - Paxman cap kit2022-03-28
B561CAPBATCH1 - Paxman Cooling cap2022-03-15

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