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Catalog item

TRACHEAL PROSTHESIS

6515FSC

01NCB code

571-4591Item number

NIIN 01-571-4591

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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	CAGE	CAGE status	RNCC	RNVC	Document availability code	RNAAC	RNFC	RNSC
H965520230	1FKE6 BOSTON SCIENTIFIC CORP	A	3	2	4	9Z	4	A
H965520230	012AK BOSTON SCIENTIFIC DO BRASIL LTDA	A	5	2	6	YA	4	A

Characteristics

OVERALL LENGTH	MILLIMETERS NOMINAL 70.0
OVERALL DIAMETER	MILLIMETERS NOMINAL 12.0
END ITEM IDENTIFICATION	GENERAL AND PLASTIC SURGERY
PART NAME ASSIGNED BY CONTROLLING AGENCY	TRACHEOBRONCHIAL STENT GRAFT
SPECIAL FEATURES	WALLGRAFT PACKAGE;STENT GRAFT DIAMETER 12MM;STENT GRAFT LENGTH 70MM;DELIVERY SYSTEM PROFILE 11F;INDICATIONS FOR USE-TREATMENT OF TRACHEOBRONCIAL STRICTURES PRODUCED BY MALIGNANT NEOPLASMS OR IN BENIGN STRICTURES AFTER ALL ALTERNATIVE THERAPIES HAVE BEEN EXHAUSTED
FUNCTIONAL DESCRIPTION	TRACHEAL PROSTHESIS
REFERENCE DATA AND LITERATURE	21 CFR 878.3720
SPECIAL TEST FEATURES	FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN
SUPPLEMENTARY FEATURES	510(K) NUMBER K021901;REGULATORY CLASS II;INTERIOR TUBE OF THE COXIAL 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 DESCRIPTION	WALLGRAFT 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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