FDA.reportPublic FDA data

Captivator™ COLD

Primary DI
08714729971252
Brand
Captivator™ COLD
Company
BOSTON SCIENTIFIC CORPORATION
Model
M00561100
Device description
Single-Use Snare
Published
2018-06-14
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

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
08714729971269PackageGS110In Commercial Distribution
08714729984979PackageGS120In Commercial Distribution
08714729984986PackageGS140In Commercial Distribution
08714729971252PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729971269087147299712698714729971269
08714729984979087147299849798714729984979
08714729984986087147299849868714729984986
08714729971252087147299712528714729971252

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

Regulatory Flags#

DUNS number
021717889
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08714729142201EndoVive Low Profile Replacement ButtonM005627702016-09-24
08714729142218EndoVive Low Profile Replacement ButtonM005628302016-09-24
08714729149200EndoVive™ One Step Button™M00568450M005684502018-09-07
08714729149217EndoVive™ One Step Button™M00568470M005684702018-09-07
08714729149224EndoVive™ One Step Button™M00568500M005685002018-09-07
08714729149231EndoVive™ One Step Button™M00568520M005685202018-09-07
08714729149934EndoVive™ One Step Button™M00568480M005684802018-09-07
08714729149941EndoVive™ One Step Button™M00568530M005685302018-09-07
08714729150084EndoVive™ One Step Button™M00568460M005684602018-09-07
08714729151081EndoVive™ One Step Button™M00568510M005685102018-09-07
08714729284017EndoVive Low Profile Replacement ButtonM005627602016-09-24
08714729284024EndoVive Low Profile Replacement ButtonM005627802016-09-24
08714729284031EndoVive Low Profile Replacement ButtonM005627902016-09-24
08714729284048EndoVive Low Profile Replacement ButtonM005628002016-09-24
08714729284062EndoVive Low Profile Replacement ButtonM005628202016-09-24
08714729284079EndoVive Low Profile Replacement ButtonM005628402016-09-24
08714729284086EndoVive Low Profile Replacement ButtonM005628502016-09-24
08714729821717Radial Jaw 4M005151802016-09-24
08714729821731Radial Jaw 4M005151902016-09-24
08714729821748Radial Jaw 4M005152002016-09-24

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