FDA.reportPublic FDA data

PROFILE

Primary DI
08714729156628
Brand
PROFILE
Company
BOSTON SCIENTIFIC CORPORATION
Model
M00562530
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
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FDISNARE, FLEXIBLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDISnare, FlexibleGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729156628PackageGS110In Commercial Distribution
08714729748014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729156628087147291566288714729156628
08714729748014087147297480148714729748014

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, monopolar, single-useAn electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece and requires a patient contact return electrode; it may include a suction/irrigation lumen and may feature a magnetic guidance sensor for electromagnetic tracking. It is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe) and may also be designed to mechanically cut tissues. This is a single-use device.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021717889
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
00191506004583WATCHMAN FLX™ ProM635WU60200M635WU602002023-09-12
00191506004590WATCHMAN FLX™ ProM635WU60240M635WU602402023-09-12
00191506004606WATCHMAN FLX™ ProM635WU60270M635WU602702023-09-12
00191506004613WATCHMAN FLX™ ProM635WU60310M635WU603102023-09-12
00191506004620WATCHMAN FLX™ ProM635WU60350M635WU603502023-09-12
00191506004637WATCHMAN FLX™ ProM635WU60400M635WU604002023-09-12
08714729195573RotaWire™ and wireClip™ TorquerH802232390010H8022323900102014-09-24
08714729195566RotaWire™ and wireClip™ TorquerH802228240020H8022282400202014-09-24
08714729837527Stingray™H749M3004A02016-09-24
08714729877523EP XT™M0042007720M00420077202016-09-24
08714729877714Dynamic XT™M0042011120M00420111202016-09-24
08714729879947EP XT™M0046EPXT00390M0046EPXT003902016-09-24
08714729181088Percuflex™ BiliaryM005337602015-09-24
08714729181095Percuflex™ BiliaryM005337702015-09-24
08714729181101Percuflex™ BiliaryM005337802015-09-24
08714729181118Percuflex™ BiliaryM005337902015-09-24
08714729181125Percuflex™ BiliaryM005338002015-09-24
08714729181132Percuflex™ BiliaryM005338102015-09-24
08714729181149Percuflex™ BiliaryM005338202015-09-24
08714729181156Percuflex™ BiliaryM005338302015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10724995220058Roth NetUS EndoscopyFDI2024-11-25
16932503552056ADVANTIS(TM) Polypectomy SnareMicro-Tech (Nanjing) Co., Ltd.FDI2024-11-08
16932503552063ADVANTIS(TM) Polypectomy SnareMicro-Tech (Nanjing) Co., Ltd.FDI2024-11-08
00724995226732Padlock ClipUS EndoscopyFDI2024-10-31
16970057575015Disposable Polyp SnareJiangsu Vedkang Medical Science and Technology Co.,Ltd.FDI2024-08-20
16970057575039Disposable Polyp SnareJiangsu Vedkang Medical Science and Technology Co.,Ltd.FDI2024-08-20
16970057575046Disposable Polyp SnareJiangsu Vedkang Medical Science and Technology Co.,Ltd.FDI2024-08-20
16970057575084Disposable Polyp SnareJiangsu Vedkang Medical Science and Technology Co.,Ltd.FDI2024-08-20
16970057575138Disposable Polyp SnareJiangsu Vedkang Medical Science and Technology Co.,Ltd.FDI2024-08-20
16970057575183Disposable Polyp SnareJiangsu Vedkang Medical Science and Technology Co.,Ltd.FDI2024-08-20
16970057575251Disposable Polyp SnareJiangsu Vedkang Medical Science and Technology Co.,Ltd.FDI2024-08-20
16970057575336Disposable Polyp SnareJiangsu Vedkang Medical Science and Technology Co.,Ltd.FDI2024-08-20
16970057577552Disposable Polyp SnareJiangsu Vedkang Medical Science and Technology Co.,Ltd.FDI2024-08-20
16970057575275Disposable Polyp SnareJiangsu Vedkang Medical Science and Technology Co.,Ltd.FDI2024-08-17
06934415066112ZKSKBeijing ZKSK Technology Co.,LtdFDI2023-12-25
06934415066129ZKSKBeijing ZKSK Technology Co.,LtdFDI2023-12-25
06934415066136ZKSKBeijing ZKSK Technology Co.,LtdFDI2023-12-25
06934415066143ZKSKBeijing ZKSK Technology Co.,LtdFDI2023-12-25
06934415066150ZKSKBeijing ZKSK Technology Co.,LtdFDI2023-12-25
06934415066167ZKSKBeijing ZKSK Technology Co.,LtdFDI2023-12-25
06934415066174ZKSKBeijing ZKSK Technology Co.,LtdFDI2023-12-25
06934415066181ZKSKBeijing ZKSK Technology Co.,LtdFDI2023-12-25
06934415066198ZKSKBeijing ZKSK Technology Co.,LtdFDI2023-12-25
06934415066204ZKSKBeijing ZKSK Technology Co.,LtdFDI2023-12-25
06934415066211ZKSKBeijing ZKSK Technology Co.,LtdFDI2023-12-25
06934415066228ZKSKBeijing ZKSK Technology Co.,LtdFDI2023-12-25
06934415066235ZKSKBeijing ZKSK Technology Co.,LtdFDI2023-12-25
06934415066242ZKSKBeijing ZKSK Technology Co.,LtdFDI2023-12-25
06934415066259ZKSKBeijing ZKSK Technology Co.,LtdFDI2023-12-25
06934415066266ZKSKBeijing ZKSK Technology Co.,LtdFDI2023-12-25