FDA.reportPublic FDA data

CAPTIVATOR II

Primary DI
08714729861355
Brand
CAPTIVATOR II
Company
BOSTON SCIENTIFIC CORPORATION
Model
M00561240
Device description
Single-Use Polypectomy Snare
Published
2016-09-24
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
FDISNARE, FLEXIBLE
FGXSNARE, NON-ELECTRICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDISnare, FlexibleGastroenterology, Urology2
FGXSnare, Non-ElectricalGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729855927PackageGS110In Commercial Distribution
08714729861362PackageGS120In Commercial Distribution
08714729861379PackageGS140In Commercial Distribution
08714729861355PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729855927087147298559278714729855927
08714729861362087147298613628714729861362
08714729861379087147298613798714729861379
08714729861355087147298613558714729861355

GMDN Terms#

Term, Definition table
TermDefinition
Flexible polypectomy snare, single-useA flexible device intended to be inserted through an endoscope to ligate, cauterize, and cut polyps, or other mucosal lesions in the gastrointestinal (GI) tract, using high frequency current. It typically consists of a flexible insulated insertion sheath, a snare loop attached to the distal end of the sheath, and an operating wire connected to both the loop and a handle which controls the operating wire. The proximal end of the operating wire is connected to a high frequency power supply unit. 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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08714729424246Contour™M0061802311202015-09-24
08714729457923Percuflex™M0061453600502015-09-24
08714729460282Percuflex™ PlusM0061751980602015-09-24
08714729460398Percuflex™ PlusM0061752500602015-09-24
08714729460657Percuflex™ PlusM0061752600502015-09-24
08714729461012Percuflex™ PlusM0061752650602015-09-24
08714729766629Polaris™ UltraM0061921401902015-09-24
08714729766735Polaris™ UltraM0061921441702015-09-24
08714729766759Polaris™ UltraM0061921451202015-09-24
08714729766766Polaris™ UltraM0061921451702015-09-24
08714729766803Polaris™ UltraM0061921501902015-09-24
08714729766841Polaris™ UltraM0061921521202015-09-24
08714729766919Polaris™ UltraM0061921541702015-09-24
08714729766926Polaris™ UltraM0061921541902015-09-24
08714729776307Contour™M0061802351702015-09-24
08714729776680Contour™M0061802301802015-09-24
08714729777137Polaris™ UltraM0061921401802015-09-24
08714729777199Polaris™ UltraM0061921501802015-09-24
08714729777205Polaris™ UltraM0061921511802015-09-24
08714729777441Polaris™ LoopM0061552250902015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936603211625Disposable Polypectomy Cold SnareYangzhou Fartley Medical Instrument Technology Co., LtdFGX2026-10-22
06936603211649Disposable Polypectomy Cold SnareYangzhou Fartley Medical Instrument Technology Co., LtdFGX2026-10-22
06936603211724Disposable Polypectomy SnareYangzhou Fartley Medical Instrument Technology Co., LtdFDI2026-10-22
06936603222119Disposable Polypectomy Cold SnareYangzhou Fartley Medical Instrument Technology Co., LtdFGX2026-10-22
06936603222515Disposable Polypectomy Cold SnareYangzhou Fartley Medical Instrument Technology Co., LtdFGX2026-10-22
06936603223260Disposable Polypectomy Cold SnareYangzhou Fartley Medical Instrument Technology Co., LtdFGX2026-10-22
06936603223277Disposable Polypectomy Cold SnareYangzhou Fartley Medical Instrument Technology Co., LtdFGX2026-10-22
06936534328911Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534328928Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534328935Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534328942Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534328959Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534328966Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534328973Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534328980Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534328997Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329000Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329017Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329024Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329031Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329048Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329055Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329062Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329079Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329086Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329093Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329109Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329116Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329123Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329130Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29