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Catalog item

TRACHEAL PROSTHESIS

6515FSC
01NCB code
571-4601Item number
NIIN 01-571-4601
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DEMIL code
A

Identification

Item name code
77777
PINC
1880795
Criticality code
X
II
0
DEMIL code
A
DEMIL integrity code
1
NIIN assigned
04-FEB-09
Precious metals indicator
A
ADP equipment code
0
Hazardous material indicator
N
ESD/EMI code
A

Part numbers

Part number
H965520330
CAGE
1FKE6
BOSTON SCIENTIFIC CORP
CAGE status
A
RNCC
3
RNVC
2
Document availability code
4
RNAAC
9Z
RNFC
4
RNSC
A

Characteristics

OVERALL LENGTHMILLIMETERS NOMINAL 70.0
OVERALL DIAMETERMILLIMETERS NOMINAL 14.0
END ITEM IDENTIFICATIONGENERAL AND PLASTIC SURGERY
PART NAME ASSIGNED BY CONTROLLING AGENCYTRACHEOBRONCHIAL STENT GRAFT
SPECIAL FEATURESWALLGRAFT PACKAGE;STENT GRAFT DIAMETER 14MM;STENT GRAFT LENGTH 70MM;DELIVERY SYSTEM PROFILE 12F;INDICATIONS FOR USE-TREATMENT OF TRACHEOBRONCIAL STRICTURES PRODUCED BY MALIGNANT NEOPLASMS OR IN BENIGN STRICTURES AFTER ALL ALTERNATIVE THERAPIES HAVE BEEN EXHAUSTED
FUNCTIONAL DESCRIPTIONTRACHEAL PROSTHESIS
REFERENCE DATA AND LITERATURE21 CFR 878.3720
SPECIAL TEST FEATURESFEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN
SUPPLEMENTARY FEATURES510(K) NUMBER K021901;REGULATORY CLASS II;INTERIOR TUBE OF THE COAXIAL SYSTEM CONTAINS A CENTRAL LUMEN WHICH WILL ACCOMMODATE A 0.035INCH GUIDE WIRE;THE DELIVERY SYSTEM WILL BE AVAILABLE IN A SINGLE WORKING LENGTH OF 90CM
GENERAL CHARACTERISTICS ITEM DESCRIPTIONWALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

MOE rules

MOE rule
YA01
MOE CD
YA
Date assigned
01-FEB-09
PICA
YA
PICA LOA
81
Auth collab
YA

Freight

ACTY CD
MB

Related items

Standardization

Item standardization code
5
Orig stdzn dec
97
Dt stdzn dec
04-FEB-2009
NIIN status code
0

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