Sunset Ruby Style Chin Strap – Fully Adjustable CS007-ADJ

GUDID 10848530082182

Sunset Ruby Style Chin Strap – Fully Adjustable

SUNSET HEALTHCARE SOLUTIONS, INC.

Anaesthesia mask strap, reusable
Primary Device ID10848530082182
NIH Device Record Key3c70c66d-48ae-49ab-bf2f-a0db29ad4320
Commercial Distribution StatusIn Commercial Distribution
Brand NameSunset Ruby Style Chin Strap – Fully Adjustable
Version Model NumberCS007-ADJ
Catalog NumberCS007-ADJ
Company DUNS141668116
Company NameSUNSET HEALTHCARE SOLUTIONS, 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 Batchtrue
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
GS100848530082185 [Primary]
GS110848530082182 [Package]
Contains: 00848530082185
Package: [90 Units]
In Commercial Distribution

FDA Product Code

BTKStrap, Head, Gas Mask

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-18
Device Publish Date2018-09-17

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