G-ARMOR STENT® 614739

GUDID 04046955767250

G ARMOR GCM017 5.7CM 12MM 6CM 14F

B BRAUN INTERVENTIONAL SYSTEMS, INC

Bare-metal aortic stent
Primary Device ID04046955767250
NIH Device Record Key9a37fb89-2f19-43bf-bea8-2d522b409799
Commercial Distribution StatusIn Commercial Distribution
Brand NameG-ARMOR STENT®
Version Model Number614739
Catalog Number614739
Company DUNS784259751
Company NameB BRAUN INTERVENTIONAL SYSTEMS, INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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

Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104046955767250 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PNFAortic stent

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-16
Device Publish Date2022-05-07

On-Brand Devices [G-ARMOR STENT®]

04046955768042G ARMOR COVERED GC8Z63
04046955768035G ARMOR COVERED GC8Z57
04046955768028G ARMOR COVERED GC8Z52
04046955768011G ARMOR COVERED GC8Z46
04046955768004G ARMOR COVERED GC10Z63
04046955767991G ARMOR COVERED GC10Z57
04046955767984G ARMOR COVERED GC10Z52
04046955767977G ARMOR COVERED GC10Z46
04046955767960G ARMOR GM044 6.3CM 30MM 6.5CM 16F
04046955767953G ARMOR GM043 6.3CM 28MM 6.5CM 16F
04046955767946G ARMOR GM042 6.3CM 26MM 6.5CM 16F
04046955767939G ARMOR GM041 5.7CM 30MM 6CM 16F
04046955767922G ARMOR GM040 5.7CM 28MM 6CM 16F
04046955767915G ARMOR GM039 5.7CM 26MM 6CM 16F
04046955767908G ARMOR GM038 5.2CM 30MM 5.5CM 16F
04046955767892G ARMOR GM037 5.2CM 28MM 5.5CM 16F
04046955767885G ARMOR GM036 5.2CM 26MM 5.5CM 16F
04046955767878G ARMOR GM035 4.6CM 30MM 5CM 16F
04046955767861G ARMOR GM034 4.6CM 28MM 5CM 16F
04046955767854G ARMOR GM033 4.6CM 26MM 5CM 16F
04046955767847G ARMOR GM032 6.3CM 24MM 6.5CM 14F
04046955767830G ARMOR GM031 6.3CM 22MM 6.5CM 14F
04046955767823G ARMOR GM030 6.3CM 20MM 6.5CM 14F
04046955767816G ARMOR GM029 6.3CM 18MM 6.5CM 14F
04046955767809G ARMOR GM028 6.3CM 16MM 6.5CM 14F
04046955767793G ARMOR GM027 6.3CM 15MM 6.5CM 13F
04046955767786G ARMOR GM026 6.3CM 14MM 6.5CM 13F
04046955767779G ARMOR GM025 6.3CM 12MM 6.5CM 13F
04046955767762G ARMOR GM024 5.7CM 24MM 6CM 14F
04046955767755G ARMOR GM023 5.7CM 22MM 6CM 14F
04046955767748G ARMOR GM022 5.7CM 20MM 6CM 14F
04046955767731G ARMOR GM021 5.7CM 18MM 6CM 14F
04046955767724G ARMOR GM020 5.7CM 16MM 6CM 14F
04046955767717G ARMOR GM019 5.7CM 15MM 6CM 13F
04046955767700G ARMOR GM018 5.7CM 14MM 6CM 13F
04046955767694G ARMOR GM017 5.7CM 12MM 6CM 13F
04046955767687G ARMOR GM016 5.2CM 24MM 5.5CM 14F
04046955767670G ARMOR GM015 5.2CM 22MM 5.5CM 14F
04046955767663G ARMOR GM014 5.2CM 20MM 5.5CM 14F
04046955767656G ARMOR GM013 5.2CM 18MM 5.5CM 14F
04046955767649G ARMOR GM012 5.2CM 16MM 5.5CM 14F
04046955767632G ARMOR GM011 5.2CM 15MM 5.5CM 13F
04046955767625G ARMOR GM010 5.2CM 14MM 5.5CM 13F
04046955767618G ARMOR GM009 5.2CM 12MM 5.5CM 13F
04046955767601G ARMOR GM008 4.6CM 24MM 5CM 14F
04046955767595G ARMOR GM007 4.6CM 22MM 5CM 14F
04046955767588G ARMOR GM006 4.6CM 20MM 5CM 14F
04046955767571G ARMOR GM005 4.6CM 18MM 5CM 14F
04046955767564G ARMOR GM004 4.6CM 16MM 5CM 14F
04046955767557G ARMOR GM003 4.6CM 15MM 5CM 13F

Trademark Results [G-ARMOR STENT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
G-ARMOR STENT
G-ARMOR STENT
90495603 not registered Live/Pending
NUMED, INC.
2021-01-28

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.