Paxman Cooling cap

GUDID B561CAPSIZINGPACKA1

PAXMAN COOLERS LIMITED

Scalp cooling system
Primary Device IDB561CAPSIZINGPACKA1
NIH Device Record Key3d32b432-a990-4e58-92f8-df60f84f04aa
Commercial Distribution StatusIn Commercial Distribution
Brand NamePaxman Cooling cap
Version Model NumberSizing pack Asian
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
HIBCCB561CAPSIZINGPACKA1 [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 Number1
Public Version Date2022-03-15
Device Publish Date2022-03-07

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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