Key Surgical Polypectomy Snare

GUDID 00849771039075

Polypectomy Snare, Stiff Multi-Wire, Oval, 15mm W

KEY SURGICAL, INC.

Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
Primary Device ID00849771039075
NIH Device Record Key3f7af0f1-03d2-4ebf-a929-90f50c9eeedf
Commercial Distribution StatusIn Commercial Distribution
Brand NameKey Surgical Polypectomy Snare
Version Model NumberEN10307B
Company DUNS604056226
Company NameKEY SURGICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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 Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8005417995
Emailregulatory@keysurgical.com
Phone8005417995
Emailregulatory@keysurgical.com
Phone8005417995
Emailregulatory@keysurgical.com
Phone8005417995
Emailregulatory@keysurgical.com
Phone8005417995
Emailregulatory@keysurgical.com
Phone8005417995
Emailregulatory@keysurgical.com
Phone8005417995
Emailregulatory@keysurgical.com
Phone8005417995
Emailregulatory@keysurgical.com
Phone8005417995
Emailregulatory@keysurgical.com
Phone8005417995
Emailregulatory@keysurgical.com
Phone8005417995
Emailregulatory@keysurgical.com

Device Dimensions

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Operating and Storage Conditions

Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100849771039068 [Primary]
GS100849771039075 [Package]
Contains: 00849771039068
Package: Box [10 Units]
In Commercial Distribution
GS110849771039072 [Package]
Package: Case [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FDISnare, Flexible

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-20
Device Publish Date2020-02-12

On-Brand Devices [Key Surgical Polypectomy Snare ]

10849771039133Polypectomy Snare, Stiff Multi-Wire, Mini-Oval, 10mm W
00849771039112Polypectomy Snare, Stiff Multi-Wire, Oval, 30mm W
00849771039099Polypectomy Snare, Stiff Multi-Wire, Oval, 25mm W
00849771039075Polypectomy Snare, Stiff Multi-Wire, Oval, 15mm W
00849771039044Polypectomy Snare, Stiff Multi-Wire, Oval, 10mm W
00849771039006Polypectomy Snare, Stiff Multi-Wire, Hexagonal, 25mm W
00849771038986Polypectomy Snare, Stiff Multi-Wire, Hexagonal, 15mm W
10849771038969Polypectomy Snare, Stiff Multi-Wire, Hexagonal, 10mm W

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