FDA.reportPublic FDA data

V. Mueller

Primary DI
10885403034992
Brand
V. Mueller
Company
CAREFUSION 2200, INC
Model
CH8320
Catalog number
CH8320
Device description
"V. Mueller NEW ORLEANS ENDARTERECTOMY STRIPPER SET SIZES 4, 5, 6, 7 AND 9MM ON 12"" (30.5CM) HANDLE"
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWXSTRIPPER, ARTERY, INTRALUMINAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWXStripper, Artery, IntraluminalCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885403034992PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540303499210885403034992

GMDN Terms#

Term, Definition table
TermDefinition
Intraluminal artery stripper, reusableA hand-held manual surgical instrument designed to perform an endarterectomy (the removal of plaque deposits from arteriosclerotic arteries) during a vasculature reconstruction procedure. It is typically made of high-grade stainless steel and is available in various designs including the "MollRing cutter". Indications for its use include disabling claudication, ischemic pain at rest, ischemic skin lesions, or gangrene. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-9088gmb-MedSpec-CustService@carefusion.com
+1(800)323-9088Customer_Support@BD.com

Regulatory Flags#

DUNS number
832696038
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885403057229JamshidiBAK4508BAK45082016-09-23
10885403057236JamshidiBAK4511BAK45112016-09-23
10885403057267JamshidiBEK4511BEK45112016-09-30
10885403075971PleurX50-7000B50-7000B2017-09-15
10885403076022Denver42-301942-30192017-06-12
10885403076046Denver42-900042-90002017-06-12
10885403107702JamshidiBCTM3411SPBCTM3411SP2016-09-30
10885403108365Safe-T-CentesisPIG1260TPIG1260T2018-07-18
10885403108389Safe-T-CentesisPIG1260TSPPIG1260TSP2018-07-18
10885403108402Safe-T-CentesisPIG1280TPIG1280T2018-07-18
10885403108426Safe-T-CentesisPIG1280TSPPIG1280TSP2018-07-18
10885403108433Safe-TTPT1000SPTPT1000SP2018-07-18
10885403108488NATPT1000TPT10002018-07-18
10885403108495Safe-TTPT1000SDFTPT1000SDF2018-07-18
10885403220852NATPT1005TPT10052018-07-18
10885403220869Safe-TTPT1005SPTPT1005SP2018-07-18
10885403228131Safe-TTPT1005SDFTPT1005SDF2018-07-18
10885403231780JamshidiBAK4511DFBAK4511DF2016-09-23
10885403231896Safe-T-CentesisPIG1260TCDFPIG1260TCDF2018-07-18
10885403231902NATPT1000CDFTPT1000CDF2018-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000358822NAMEDTRONIC, INC.DWX2020-02-17
04953170047671VALVULOTOME (DETACHABLE TYPE)OLYMPUS MEDICAL SYSTEMS CORP.DWX2016-09-21
04953170047695VALVULOTOME (DETACHABLE TYPE)OLYMPUS MEDICAL SYSTEMS CORP.DWX2016-09-21
14953170047678VALVULOTOME (DETACHABLE TYPE)OLYMPUS MEDICAL SYSTEMS CORP.DWX2016-09-21
14953170047692VALVULOTOME (DETACHABLE TYPE)OLYMPUS MEDICAL SYSTEMS CORP.DWX2016-09-21
24026704518955PILLINGTELEFLEX INCORPORATEDDWX2016-09-16
24026704518962PILLINGTELEFLEX INCORPORATEDDWX2016-09-16
04026704518944PillingTELEFLEX INCORPORATEDDWX2016-09-16
04026704518951PillingTELEFLEX INCORPORATEDDWX2016-09-16
04026704518968PillingTELEFLEX INCORPORATEDDWX2016-09-16
00840663102693MollRing Cutter Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663102709MollRing Cutter Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663102716MollRing Cutter Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663102723MollRing Cutter Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663102730MollRing Cutter Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663102747MollRing Cutter Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663105823MultiTASC Dissection/Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663105830MultiTASC Dissection/Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663105847MultiTASC Dissection/Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663105854MultiTASC Dissection/Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663105861MultiTASC Dissection/Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663105878MultiTASC Dissection/Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663105885MultiTASC Dissection/Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663105892MultiTASC Dissection/Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663105908MultiTASC Dissection/Transection Device sizing toolLemaitre Vascular, Inc.DWX2015-07-15
00840663102563Periscope DissectorLemaitre Vascular, Inc.DWX2015-06-30
00840663102570Martin DissectorLemaitre Vascular, Inc.DWX2015-06-30
00840663102587EndoHelix Retrieval DeviceLemaitre Vascular, Inc.DWX2015-06-30