AngelMed Guardian Programmer External Power Accessories 0204-2100-093#P10

GUDID 00850012625100

PROG-003 External Power Accessories Kit (US)

Angel Medical Systems, Inc.

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Primary Device ID00850012625100
NIH Device Record Keyfe24b0fc-e8a1-495c-8c93-66700990266f
Commercial Distribution StatusIn Commercial Distribution
Brand NameAngelMed Guardian Programmer External Power Accessories
Version Model Number0204-2100-093#P10
Catalog Number0204-2100-093#P10
Company DUNS171391779
Company NameAngel Medical Systems, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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
GS100850012625100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QBIAcute coronary syndrome event detector

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-05
Device Publish Date2021-02-25

Devices Manufactured by Angel Medical Systems, Inc.

00850012625001 - AngelMed Guardian IMD Model AMSG3-E2021-03-11 IMD AMSG3-E Kit
00850012625018 - AngelMed Guardian Torque Wrench2021-03-05 Hex Torque Wrench (Separate, in Sterile Pack)
00850012625025 - AngelMed Guardian EXD Model EXD-0012021-03-05 EXD-001 Kit
00850012625032 - AngelMed Guardian EXD Model EXD-0012021-03-05 EXD-001 Kit (Latin-American Spanish)
00850012625049 - AngelMed Guardian EXD Carrying Case2021-03-05 EXD Carrying Case
00850012625056 - AngelMed Guardian EXD Lanyard2021-03-05 EXD Lanyard
00850012625063 - AngelMed Guardian Programmer Model PROG-0032021-03-05 PROG-003 Kit (US)
00850012625070 - AngelMed Guardian Programmer Wand EXD Model EXD-0012021-03-05 PROG-003 Wand

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