AtriClip FLEX•V A001019

GUDID 00818354016178

AtriClip FLEX•V device 45

ATRICURE, INC.

Ligation clip, metallic
Primary Device ID00818354016178
NIH Device Record Keyd3fb2536-ff7e-4aa5-8964-686eb34d00e7
Commercial Distribution StatusIn Commercial Distribution
Brand NameAtriClip FLEX•V
Version Model NumberACHV45
Catalog NumberA001019
Company DUNS006133784
Company NameATRICURE, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length45 Millimeter
Length45 Millimeter
Length45 Millimeter
Length45 Millimeter
Length45 Millimeter
Length45 Millimeter
Length45 Millimeter
Length45 Millimeter
Length45 Millimeter
Length45 Millimeter
Length45 Millimeter
Length45 Millimeter
Length45 Millimeter

Operating and Storage Conditions

Handling Environment TemperatureBetween 20 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 0 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100818354016178 [Primary]

FDA Product Code

FZPClip, Implantable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-15
Device Publish Date2018-02-20

On-Brand Devices [AtriClip FLEX•V]

00818354016185AtriClip FLEX•V device 50
00818354016178AtriClip FLEX•V device 45
00818354016161AtriClip FLEX•V device 40
00818354016154AtriClip FLEX•V device 35
30840143900161AtriClip FLEX•V device 50
30840143900154AtriClip FLEX•V device 45
30840143900147AtriClip FLEX•V device 40
30840143900130AtriClip FLEX•V device 35
10840143901324AtriClip FLEX•V device 50
10840143901300AtriClip FLEX•V device 45
10840143901287AtriClip FLEX•V device 40
10840143901263AtriClip FLEX•V device 35

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.