Positioning Aids THS03

GUDID 10628341930236

Cranial Head Support

CDR Systems Inc

Radiological headrest
Primary Device ID10628341930236
NIH Device Record Key9b868e63-03af-48fd-a554-00c6d439c971
Commercial Distribution StatusIn Commercial Distribution
Brand NamePositioning Aids
Version Model Number1
Catalog NumberTHS03
Company DUNS206950904
Company NameCDR Systems 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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone403-850-7035
Emailinfo@cdrsys.ca

Device Identifiers

Device Issuing AgencyDevice ID
GS100628341930239 [Primary]
GS110628341930236 [Package]
Contains: 00628341930239
Package: [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYEAccelerator, Linear, Medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-08
Device Publish Date2019-12-31

On-Brand Devices [Positioning Aids]

10628341930236Cranial Head Support
00628341930130Wedges, supports and positioning aids

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