SVR System without Patch

GUDID 00899054002371

SVR System with 130cc Mannequin™ without Patch

KDL MEDICAL, INC.

Catheter/overtube balloon inflator, single-use
Primary Device ID00899054002371
NIH Device Record Key3befa8cb-403a-443e-9ee6-24e199c163b5
Commercial Distribution StatusIn Commercial Distribution
Brand NameSVR System without Patch
Version Model NumberSVC-0130S
Company DUNS791048924
Company NameKDL MEDICAL, 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 Numberfalse
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
GS100899054002371 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-05-06
Device Publish Date2017-05-23

On-Brand Devices [SVR System without Patch]

00899054002395SVR System with 150cc Mannequin™ without Patch
00899054002388SVR System with 140cc Mannequin™ without Patch
00899054002371SVR System with 130cc Mannequin™ without Patch
00899054002364SVR System with 120cc Mannequin™ without Patch
00899054002357SVR System with 110cc Mannequin™ without Patch
00899054002340SVR System with 100cc Mannequin™ without Patch
00899054002333SVR System with 90cc Mannequin™ without Patch
00899054002326SVR System with 85cc Mannequin™ without Patch
00899054002166SVR System with 80cc Mannequin™ without Patch

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