FDA.reportPublic FDA data

Key Surgical Polypectomy Snare

Primary DI
10849771039133
Brand
Key Surgical Polypectomy Snare
Company
KEY SURGICAL, INC.
Model
EN 10330
Device description
Polypectomy Snare, Stiff Multi-Wire, Mini-Oval, 10mm W
Published
2020-02-12
Public version status
New
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
FGXSnare, Non-Electrical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGXSnare, Non-ElectricalGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00849771039136PackageGS110In Commercial Distribution
10849771039133PackageGS110In Commercial Distribution
00849771039129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849771039136008497710391368497710391360849771039136
1084977103913310849771039133
00849771039129008497710391298497710391290849771039129

GMDN Terms#

Term, Definition table
TermDefinition
Mechanical-cutting endoscopic polypectomy snareA sterile, flexible, non-powered (i.e., not electrosurgical) device intended to be inserted through an endoscope to ensnare and cut polyps or other mucosal lesions during endoscopic surgery. It typically consists of a flexible sheath with a sharp cutting snare loop attached to the distal end of the sheath, and a handle which mechanically controls snaring through manual action. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure86 KiloPascal106 KiloPascal
Storage Environment Humidity080 Percent (%) Relative Humidity
Storage Environment Humidity0 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8005417995regulatory@keysurgical.com
+1(800)541-7995regulatory@keysurgical.com

Regulatory Flags#

DUNS number
604056226
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
00849771048596NAPlastic Sterilization TrayPST2100SB2023-01-26
00849771048602NAPlastic Sterilization TrayPST3100SB2023-01-26
00849771048619NAPlastic Sterilization TrayPST3200SB2023-01-26
00849771052692NAPlastic Sterilization TrayPST0100SB2023-01-26
00849771052715NAPlastic Sterilization TrayPST3200SBC12023-01-26
00849771052708NAPlastic Sterilization TrayPST1100SB2023-01-26
00849771048626NAPlastic Sterilization TraysPST3300SB2023-05-08
10849771050374NASilicone Clamp CoversVS2012023-03-31
10849771050381NASilicone Clamp CoverVS2022023-01-26
10849771050398NASilicone Clamp CoverVS2032023-01-26
00849771031284Key Surgical Silicone Clamp CoversVS-103VS1032020-12-09
00849771048367NASurgical Plastic InstrumentKS3472023-01-26
00849771048374NASurgical Plastic InstrumentsKS3482023-04-04
10849771013379Key Surgical Cautery Tip CleanerTC200NSTC200NS2025-04-04
10849771047428NAInstrument OrganizerCSDH1002022-11-22
10849771047435NAInstrument OrganizerCSDH1022022-11-22
10849771047442NAInstrument OrganizerCSDH1052022-11-22
10849771047459NAInstrument OrganizerCSDH3002022-11-22
10849771047466NAInstrument OrganizerCSDH2002022-11-22
10849771047473NAInstrument OrganizerCSDH5052022-11-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06959664902073NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902097NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902110NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902127NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902134NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902141NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902158NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902172NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902196NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902202NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902219NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902226NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902233NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902240NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902257NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902264NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902271NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902288NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902295NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902301NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664908921NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664908938NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664908945NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664908952NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664908983NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664908990NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664909003NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664909027NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664909034NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664909041NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22