Paxman Cooling Cap

GUDID B561PSCSCAPLARGE0

PAXMAN COOLERS LIMITED

Scalp cooling system
Primary Device IDB561PSCSCAPLARGE0
NIH Device Record Key61ea7890-417a-43a8-b7db-fab504bcb607
Commercial Distribution StatusIn Commercial Distribution
Brand NamePaxman Cooling Cap
Version Model NumberLarge
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 Numbertrue
Manufacturing Datetrue
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
HIBCCB561PSCSCAPLARGE0 [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

On-Brand Devices [Paxman Cooling Cap]

B561PSCSCAPSMALL0Small
B561PSCSCAPMEDIUM0Medium
B561PSCSCAPLARGE0Large
B561CAPSIZINGPACK1Sizing pack
B561PSCSCAPASIANSMALL0Small Asian
B561PSCSCAPASIANMEDIUM0Medium Asian
B561PSCSCAPASIANLARGE0Large Asian
B561PSCSCAPMEDSML0Medium/Small
B561CAPSIZINGPACKA1Sizing pack Asian
B561CAPBATCH1Cap Batch

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