easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use L30W

GUDID 66925776123554

Loading Units, 30±2mm Long, 2.5±0.2mm height, white

Ezisurg Medical Co., Ltd.

Endoscopic manual linear cutting stapler, single-use
Primary Device ID66925776123554
NIH Device Record Key21166868-2bda-43c1-bcd5-628088977f37
Commercial Distribution StatusIn Commercial Distribution
Brand NameeasyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use
Version Model NumberL30W
Catalog NumberL30W
Company DUNS421348845
Company NameEzisurg Medical Co., Ltd.
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 20 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 20 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 20 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 20 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 20 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 20 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 20 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 20 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 20 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 20 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 20 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 20 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 20 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 20 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS106925776123552 [Primary]
GS166925776123554 [Package]
Contains: 06925776123552
Package: color box [6 Units]
In Commercial Distribution
GS176925776123551 [Package]
Package: traveling case [3 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GDWStaple, Implantable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-01-15
Device Publish Date2025-01-07

On-Brand Devices [easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use]

66925776123646Loading Units, 60±2mm Long, 4.1±0.2mm height, green
66925776123639Loading Units, 60±2mm Long, 3.8±0.2mm height, gold
66925776123622Loading Units, 60±2mm Long, 3.5±0.2mm height, blue
66925776123615Loading Units, 60±2mm Long, 2.5±0.2mm height, white
66925776123608Loading Units, 45±2mm Long, 4.1±0.2mm height, green
66925776123592Loading Units, 45±2mm Long, 3.8±0.2mm height, gold
66925776123585Loading Units, 45±2mm Long, 2.5±0.2mm height, white
66925776123578Loading Units, 45±2mm Long, 2.5±0.2mm height, white
66925776123561Loading Units, 30±2mm Long, 3.5±0.2mm height, blue
66925776123554Loading Units, 30±2mm Long, 2.5±0.2mm height, white
66925776123547Loading Units, 60±2mm Long, 4.1±0.2mm height, green
66925776123530Loading Units, 60±2mm Long,3.8±0.2mm height, gold
66925776123523Loading Units, 60±2mm Long, 3.5±0.2mm height, blue
66925776123516Loading Units, 60±2mm Long, 2.5±0.2mm height, white
66925776123509Loading Units, 45±2mm Long, 4.1±0.2mm height, green
66925776123493Loading Units, 45±2mm Long, 3.8±0.2mm height, gold
66925776123486Loading Units, 45±2mm Long, 3.5±0.2mm height, blue
66925776123479Loading Units, 45±2mm Long, 2.5±0.2mm height, white
66925776123462Loading Units, 30±2mm Long, 3.5±0.2mm height, blue
66925776123455Loading Units, 30±2mm Long, 2.5±0.2mm height, white
16925776123443Linear Cutting Stapler, 250±25mm Long
16925776123436Linear Cutting Stapler, 160±16mm Long
16925776123429Linear Cutting Stapler, 70±7mm Long
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