FDA.reportPublic FDA data

Exacto

Primary DI
00724995182564
Brand
Exacto
Company
US Endoscopy
Model
00711095
Catalog number
00711095
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
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
10724995182561PackageGS150In Commercial Distribution
00724995182564PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072499518256110724995182561
00724995182564007249951825647249951825640724995182564

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.

Contacts#

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

Regulatory Flags#

DUNS number
627879687
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995182557Exacto00711094007110942021-03-31
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
00724995181000VIA00717007007170072020-02-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809909421457SnareTAEWOONGMEDICAL.CO.,LTDFGX2026-04-27
08809909421464SnareTAEWOONGMEDICAL.CO.,LTDFGX2026-04-27
08809909421471SnareTAEWOONGMEDICAL.CO.,LTDFGX2026-04-27
08809909421488SnareTAEWOONGMEDICAL.CO.,LTDFGX2026-04-27
46932503554518EnTrap(TM) Polyp Retrieval Snare NetMicro-Tech (Nanjing) Co., Ltd.FGX2025-12-06
46932503554525EnTrap(TM) Polyp Retrieval Snare NetMicro-Tech (Nanjing) Co., Ltd.FGX2025-12-06
56932503554515EnTrap(TM) Polyp Retrieval Snare NetMicro-Tech (Nanjing) Co., Ltd.FGX2025-12-06
56932503554522EnTrap(TM) Polyp Retrieval Snare NetMicro-Tech (Nanjing) Co., Ltd.FGX2025-12-06
00724995243753Exacto MundoUS EndoscopyFGX2025-08-19
00724995243760Exacto MundoUS EndoscopyFGX2025-08-19
10724995243750Exacto MundoUS EndoscopyFGX2025-08-19
10724995243767Exacto MundoUS EndoscopyFGX2025-08-19
06932503554510EnTrap(TM) Polyp Retrieval Snare NetMicro-Tech (Nanjing) Co., Ltd.FGX2025-04-24
06932503554527EnTrap(TM) Polyp Retrieval Snare NetMicro-Tech (Nanjing) Co., Ltd.FGX2025-04-24
16932503554517EnTrap(TM) Polyp Retrieval Snare NetMicro-Tech (Nanjing) Co., Ltd.FGX2025-04-24
16932503554524EnTrap(TM) Polyp Retrieval Snare NetMicro-Tech (Nanjing) Co., Ltd.FGX2025-04-24
00724995243746Exacto MundoUS EndoscopyFGX2025-01-31
10724995243743Exacto MundoUS EndoscopyFGX2025-01-31
06936603226971Disposable Polypectomy Cold SnareYangzhou Fartley Medical Instrument Technology Co., LtdFGX2025-01-21
06936603226988Disposable Polypectomy Cold SnareYangzhou Fartley Medical Instrument Technology Co., LtdFGX2025-01-21
06936603227015Disposable Polypectomy Cold SnareYangzhou Fartley Medical Instrument Technology Co., LtdFGX2025-01-21
06936603227022Disposable Polypectomy Cold SnareYangzhou Fartley Medical Instrument Technology Co., LtdFGX2025-01-21
06941513202243Disposable Cold SnaresJiangsu Vedkang Medical Science and Technology Co.,Ltd.FGX2025-01-07
06941513202250Disposable Cold SnaresJiangsu Vedkang Medical Science and Technology Co.,Ltd.FGX2025-01-07
06941513202274Disposable Cold SnaresJiangsu Vedkang Medical Science and Technology Co.,Ltd.FGX2025-01-07
06941513202281Disposable Cold SnaresJiangsu Vedkang Medical Science and Technology Co.,Ltd.FGX2025-01-07
16941513202240Disposable Cold SnaresJiangsu Vedkang Medical Science and Technology Co.,Ltd.FGX2025-01-07
16941513202257Disposable Cold SnaresJiangsu Vedkang Medical Science and Technology Co.,Ltd.FGX2025-01-07
16941513202271Disposable Cold SnaresJiangsu Vedkang Medical Science and Technology Co.,Ltd.FGX2025-01-07
16941513202288Disposable Cold SnaresJiangsu Vedkang Medical Science and Technology Co.,Ltd.FGX2025-01-07