FDA.reportPublic FDA data

G-ARMOR STENT®

Primary DI
04046955767113
Brand
G-ARMOR STENT®
Company
B BRAUN INTERVENTIONAL SYSTEMS, INC
Model
614725
Catalog number
614725
Device description
G ARMOR GCM003 4.6cm 15mm 5cm 14F
Published
2022-05-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PNFAortic stent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PNFAortic StentUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P150028000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P150028000CHEATHAM PLATINUM (CP) STENT SYSTEM (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent)NuMED, Inc.2016-03-25PNF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046955767113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046955767113040469557671134046955767113

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius45 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)836-2228GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
784259751
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046955642489Seamless™6147026147022023-06-29
04046955668823COMPASS ™6139446139442021-12-07
04046955668847COMPASS ™6139456139452021-12-07
04046955668861COMPASS ™6139466139462021-12-07
04046955668885COMPASS ™6139476139472021-12-07
04046955668908COMPASS ™6139486139482021-12-07
04046955668922COMPASS ™6139496139492021-12-07
04046955668946COMPASS ™6139506139502021-12-07
04046955668960COMPASS ™6139516139512021-12-07
04046955668984COMPASS ™6139526139522021-12-07
04046955669004COMPASS ™6139536139532021-12-07
04046955669028COMPASS ™6139546139542021-12-07
04046955669042COMPASS ™6139556139552021-12-07
04046955669066COMPASS ™6139566139562021-12-07
04046955669080COMPASS ™6139576139572021-12-07
04046955669103COMPASS ™6139586139582021-12-07
04046955669127COMPASS ™6139596139592021-12-07
04046955669141COMPASS ™6139606139602021-12-07
04046955669165COMPASS ™6139616139612021-12-07
04046955669189COMPASS ™6139626139622021-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850075943005Minima Pro Stent System - 6mmRENATA MEDICAL, INC.PNF2026-11-02
00196852801862Minima Stent System - 6mmRENATA MEDICAL, INC.PNF2025-04-02
00196852805037Minima Stent System - 8mmRENATA MEDICAL, INC.PNF2025-04-02
04046955766932G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955766949G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767038G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767045G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767052G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767069G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767076G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767083G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767090G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767106G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767120G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767137G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767144G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767151G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767168G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767175G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767182G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767199G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767205G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767212G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767229G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767236G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767243G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767250G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767267G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767274G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767281G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07