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 ID	00849771039075
NIH Device Record Key	3f7af0f1-03d2-4ebf-a929-90f50c9eeedf
Commercial Distribution Status	In Commercial Distribution
Brand Name	Key Surgical Polypectomy Snare
Version Model Number	EN10307B
Company DUNS	604056226
Company Name	KEY SURGICAL, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	8005417995
Email	regulatory@keysurgical.com
Phone	8005417995
Email	regulatory@keysurgical.com
Phone	8005417995
Email	regulatory@keysurgical.com
Phone	8005417995
Email	regulatory@keysurgical.com
Phone	8005417995
Email	regulatory@keysurgical.com
Phone	8005417995
Email	regulatory@keysurgical.com
Phone	8005417995
Email	regulatory@keysurgical.com
Phone	8005417995
Email	regulatory@keysurgical.com
Phone	8005417995
Email	regulatory@keysurgical.com
Phone	8005417995
Email	regulatory@keysurgical.com
Phone	8005417995
Email	regulatory@keysurgical.com

Device Dimensions

Device Size Text, specify	0
Device Size Text, specify	0
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Device Size Text, specify	0
Device Size Text, specify	0
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Device Size Text, specify	0
Device Size Text, specify	0

Operating and Storage Conditions

Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 86 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 86 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 86 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 86 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 86 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 86 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 86 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 86 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 86 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 86 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849771039068 [Primary]
GS1	00849771039075 [Package] Contains: 00849771039068 Package: Box [10 Units] In Commercial Distribution
GS1	10849771039072 [Package] Package: Case [10 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K172729

FDA Product Code

FDI	Snare, Flexible

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2020-02-20
Device Publish Date	2020-02-12

On-Brand Devices [Key Surgical Polypectomy Snare ]

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