FDA.reportPublic FDA data

NanoCross™ Elite

Primary DI
00821684066485
Brand
NanoCross™ Elite
Company
Covidien LP
Model
AB14W030120150
Device description
PTA AB14W030120150 NANOCROSS 014 V04
Published
2016-04-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LITCatheter, angioplasty, peripheral, transluminal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LITCatheter, Angioplasty, Peripheral, TransluminalCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821684066485PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821684066485008216840664858216840664850821684066485

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral angioplasty balloon catheter, basicA sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length120Millimeter
Outer Diameter3Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
968903703
Device count
1
DM exempt
false
Premarket exempt
false
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521091986NellcorSC-A-I2026-05-25
20884521841724Shiley50FXLTCP2026-03-17
20884521841687Shiley50FXLTCD2026-03-16
20884521841694Shiley60FXLTCD2026-03-16
20884521841700Shiley70FXLTCD2026-03-16
20884521841717Shiley80FXLTCD2026-03-16
20884521841731Shiley60FXLTCP2026-03-16
20884521841748Shiley70FXLTCP2026-03-16
20884521841755Shiley80FXLTCP2026-03-16
20884521841762Shiley50FXLTUD2026-03-16
20884521841779Shiley60FXLTUD2026-03-16
20884521841786Shiley70FXLTUD2026-03-16
20884521841793Shiley80FXLTUD2026-03-16
20884521841809Shiley50FXLTUP2026-03-16
20884521841816Shiley60FXLTUP2026-03-16
20884521841823Shiley70FXLTUP2026-03-16
20884521841830Shiley80FXLTUP2026-03-16
30884521841844Shiley50FXLTIN2026-03-16
20884521841854Shiley60FXLTIN2026-03-16
20884521841861Shiley70FXLTIN2026-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640119558639Passeo-18Biotronik AGLIT2016-08-24
07640119558646Passeo-18Biotronik AGLIT2016-08-24
07640119558653Passeo-18Biotronik AGLIT2016-08-24
07640119558660Passeo-18Biotronik AGLIT2016-08-24
07640119558677Passeo-18Biotronik AGLIT2016-08-24
07640119558684Passeo-18Biotronik AGLIT2016-08-24
07640119558691Passeo-18Biotronik AGLIT2016-08-24
07640119558707Passeo-18Biotronik AGLIT2016-08-24
07640119558714Passeo-18Biotronik AGLIT2016-08-24
07640119558721Passeo-18Biotronik AGLIT2016-08-24
07640119558738Passeo-18Biotronik AGLIT2016-08-24
07640119558745Passeo-18Biotronik AGLIT2016-08-24
07640119558752Passeo-18Biotronik AGLIT2016-08-24
07640119558769Passeo-18Biotronik AGLIT2016-08-24
07640119558776Passeo-18Biotronik AGLIT2016-08-24
07640119558783Passeo-18Biotronik AGLIT2016-08-24
07640119558790Passeo-18Biotronik AGLIT2016-08-24
07640119558806Passeo-18Biotronik AGLIT2016-08-24
07640119558813Passeo-18Biotronik AGLIT2016-08-24
07640119558820Passeo-18Biotronik AGLIT2016-08-24
07640119558837Passeo-18Biotronik AGLIT2016-08-24
07640119558844Passeo-18Biotronik AGLIT2016-08-24
07640119558851Passeo-18Biotronik AGLIT2016-08-24
07640119558868Passeo-18Biotronik AGLIT2016-08-24
07640119558875Passeo-18Biotronik AGLIT2016-08-24
07640119558882Passeo-18Biotronik AGLIT2016-08-24
07640119558899Passeo-18Biotronik AGLIT2016-08-24
07640119558905Passeo-18Biotronik AGLIT2016-08-24
07640119558912Passeo-18Biotronik AGLIT2016-08-24
07640119558929Passeo-18Biotronik AGLIT2016-08-24