FDA.reportPublic FDA data

Resectr™

Primary DI
08714729964537
Brand
Resectr™
Company
BOSTON SCIENTIFIC CORPORATION
Model
M0065907051
Catalog number
M0065907051
Device description
Tissue Resection Device
Published
2020-01-24
Public version status
Update
Distribution status
Not 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
HIHHYSTEROSCOPE (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIHHysteroscope (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729964537PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729964537087147299645378714729964537

GMDN Terms#

Term, Definition table
TermDefinition
Hysteroscopic resection deviceA sterile, hand-held, manual surgical instrument intended to be inserted through the working channel of a hysteroscope to cut and remove uterine lesions (e.g., polyps), and may in addition be used to obtain a mucosal biopsy. It consists of a distal cannula with a side-notch and internal oscillating cutting blade, a proximal handle/operating mechanism, and may include a suction port; it does not have a snare mechanism and is not an electrosurgical device. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge5French
Outer Diameter1.65Millimeter

Sterilization Methods#

Method table
Method

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
00850006759507Aveta Cervical SealMEDITRINA, INC.HIH2026-10-05
00850083954154Resectr Resection Device 5FR (1.65 mm)Axora Medical, Inc.HIH2026-09-24
00850083954161Resectr Resection Device 9FR (3.0 mm)Axora Medical, Inc.HIH2026-09-24
00850083954352HERizon RD5 Resecting DeviceAxora Medical, Inc.HIH2026-09-24
06974880994053Manual Tissue Removal DeviceSuzhou AcuVu medical technology Co., Ltd.HIH2026-07-27
06974880994084Manual Tissue Removal DeviceSuzhou AcuVu medical technology Co., Ltd.HIH2026-07-27
06975339623418SeleneView®MacroLux Medical Technology Co., Ltd.HIH2026-07-03
00821925002104USA Elite SystemGyrus ACMI, LLCHIH2024-11-21
00821925002074USA Elite SystemGyrus ACMI, LLCHIH2024-07-25
00821925002562SlimLineGyrus ACMI, LLCHIH2024-07-24
07613327616675SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616682SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616699SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616705SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616712SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616729SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616736SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616743SPYSTRYKER CORPORATIONHIH2024-02-27
07613327624311NASTRYKER CORPORATIONHIH2024-02-27
07613327507102N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
07613327507119N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
07613327507126N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
07613327507133N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
07613327507140N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
08714729986935Cytuity™BOSTON SCIENTIFIC CORPORATIONHIH2019-08-20
10884521750203TruClearCovidien LPHIH2018-12-21
00821925004986Gyrus ACMIGyrus ACMI, LLCHIH2018-09-13
10884521744080TruClearCovidien LPHIH2017-10-16
10884521744097TruClearCovidien LPHIH2017-10-16
10884521744103TruClearCovidien LPHIH2017-10-16