FDA.reportPublic FDA data

Exacto

Primary DI
10724995182554
Brand
Exacto
Company
US Endoscopy
Model
00711094
Catalog number
00711094
Device description
The Exacto cold snare is intended to be used without diathermic energy for the endoscopic resection of polyp tissue in the gastrointestinal tract.
Published
2021-03-31
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
10724995182554PackageGS120In Commercial Distribution
00724995182557PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072499518255410724995182554
00724995182557007249951825577249951825570724995182557

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
627879687
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995182557Exacto00711094007110942021-03-31
00724995182564Exacto00711095007110952021-03-31
00724995182618Exacto00711115007111152021-03-31
00724995243746Exacto Mundo00711114007111142025-01-31
00724995180959VIA00717001007170012020-01-31
00724995181116VIA00717019007170192020-01-30
00724995181420VIA00717051007170512020-01-30
00724995181451VIA00717054007170542020-01-30
00724995181505VIA00717059007170592020-01-30
00724995181659VIA00717076007170762020-01-30
00724995182984VIA00717141007171412020-01-30
00724995183073VIA00717155007171552020-07-16
00724995183141VIA00717167007171672020-01-30
00724995183257VIA00717182007171822020-01-30
00724995190699VIA00717223007172232020-01-30
00724995190736VIA00717234007172342020-01-30
00724995193966VIA00717269007172692020-02-04
00724995194123VIA00717229007172292020-02-07
00724995194987VIA00717310007173102020-03-23
00724995203412VIA00717337007173372020-10-20

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