SUREGLIDE Guidewire 0.038" (0.97mm) x 150cm Stiff Body, 3cm Angled Ti

GUDID 00821925027244

Gyrus Acmi, Inc.

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Primary Device ID00821925027244
NIH Device Record Keye6e590e4-5598-49d1-bf94-de62e1a42da5
Commercial Distribution StatusIn Commercial Distribution
Brand NameSUREGLIDE Guidewire 0.038" (0.97mm) x 150cm Stiff Body, 3cm Angled Ti
Version Model Number44BX
Company DUNS007198742
Company NameGyrus Acmi, 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100821925027244 [Package]
Contains: 00821925031463
Package: [5 Units]
In Commercial Distribution
GS100821925031463 [Primary]

FDA Product Code

EYASTYLET, URETERAL

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-12
Device Publish Date2018-09-11

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