Guider Catheter Introducer

GUDID 00852392007040

Guider - 65cm - L1 Guider Catheter Introducer 65 L1 8.5F

RHYTHM XIENCE, INC.

Cardiac transseptal access set
Primary Device ID00852392007040
NIH Device Record Key29dc316d-b876-4f2b-9888-95f65cf83cbd
Commercial Distribution StatusIn Commercial Distribution
Brand NameGuider Catheter Introducer
Version Model Number111852
Company DUNS035028367
Company NameRHYTHM XIENCE, 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 Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
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
GS100852392007040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYBIntroducer, Catheter

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00852392007040]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-01-23
Device Publish Date2018-10-29

On-Brand Devices [Guider Catheter Introducer]

00852392007057Guider - 65cm - L2 Guider Catheter Introducer 65 L2 8.5F
00852392007040Guider - 65cm - L1 Guider Catheter Introducer 65 L1 8.5F
00852392007033Guider - 50cm - L2 Guider Catheter Introducer 50 L2 8.5F
00852392007026Guider - 50cm - L1 Guider Catheter Introducer 50 L1 8.5F

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