Morph Universal Deflectable Guide Catheter 00895

GUDID 00866749000202

BIOCARDIA, INC.

Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use
Primary Device ID00866749000202
NIH Device Record Key9e1f7d27-e3bd-47a9-83ef-10f6a300523d
Commercial Distribution StatusIn Commercial Distribution
Brand NameMorph Universal Deflectable Guide Catheter
Version Model Number00895
Catalog Number00895
Company DUNS122370146
Company NameBIOCARDIA, 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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100866749000202 [Primary]

FDA Product Code

DQOCatheter, Intravascular, Diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00866749000202]

Ethylene Oxide

[00866749000202]

Ethylene Oxide

[00866749000202]

Ethylene Oxide

[00866749000202]

Ethylene Oxide

[00866749000202]

Ethylene Oxide

[00866749000202]

Ethylene Oxide

[00866749000202]

Ethylene Oxide

[00866749000202]

Ethylene Oxide

[00866749000202]

Ethylene Oxide

[00866749000202]

Ethylene Oxide

[00866749000202]

Ethylene Oxide

[00866749000202]

Ethylene Oxide

[00866749000202]

Ethylene Oxide

[00866749000202]

Ethylene Oxide

[00866749000202]

Ethylene Oxide

[00866749000202]

Ethylene Oxide

[00866749000202]

Ethylene Oxide

[00866749000202]

Ethylene Oxide

[00866749000202]

Ethylene Oxide

[00866749000202]

Ethylene Oxide

[00866749000202]

Ethylene Oxide

[00866749000202]

Ethylene Oxide

[00866749000202]

Ethylene Oxide

[00866749000202]

Ethylene Oxide

[00866749000202]

Ethylene Oxide

[00866749000202]

Ethylene Oxide

[00866749000202]

Ethylene Oxide

[00866749000202]

Ethylene Oxide

[00866749000202]

Ethylene Oxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-01-23
Device Publish Date2016-10-10

Devices Manufactured by BIOCARDIA, INC.

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00850007221010 - Avance Steerable Introducer2023-07-26 Cardiovascular Catheter introducer
00850007221027 - Avance Steerable Catheter2023-07-26 Cardiovascular catheter introducer
00866749000271 - Helical Infusion Catheter2023-07-25 Catheter, percutaneous
00866749000295 - Morph DNA2023-07-25 Guide Catheter
00866749000202 - Morph Universal Deflectable Guide Catheter2019-01-23
00866749000202 - Morph Universal Deflectable Guide Catheter2019-01-23
00866749000240 - Morph AccessPro Steerable Introducer2019-01-23
00866749000257 - Morph AccessPro Steerable Introducer2019-01-23
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