FDA.report

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
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
DWXSTRIPPER, ARTERY, INTRALUMINAL

Product Code Classifications

CodeDeviceSpecialtyClass
DWXStripper, Artery, IntraluminalCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10885403034992PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088540303499210885403034992

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)323-9088gmb-MedSpec-CustService@carefusion.com

Regulatory Flags

DUNS number
832696038
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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04026704518944PillingTELEFLEX INCORPORATEDDWX2016-09-16
04026704518951PillingTELEFLEX INCORPORATEDDWX2016-09-16
04026704518968PillingTELEFLEX INCORPORATEDDWX2016-09-16
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