Sunset Red Style Chin Strap – Fully Adjustable-Extra Large CS007-ADJXL

GUDID 10848530082434

Sunset Red Style Chin Strap – Fully Adjustable-Extra Large

SUNSET HEALTHCARE SOLUTIONS, INC.

Anaesthesia mask strap, reusable
Primary Device ID10848530082434
NIH Device Record Key280031b0-9619-4198-b69e-b4d91072bfcc
Commercial Distribution StatusIn Commercial Distribution
Brand NameSunset Red Style Chin Strap – Fully Adjustable-Extra Large
Version Model NumberCS007-ADJXL
Catalog NumberCS007-ADJXL
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
GS100848530082437 [Primary]
GS110848530082434 [Package]
Contains: 00848530082437
Package: [70 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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