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
00685447020677RFP-100A™ RF Puncture GeneratorM004RFP100A0M004RFP100A02026-06-08
00191506049232Orbera™M00505670M005056702026-06-04
08714729121190Ultraflex™ Esophageal NGM005142002015-09-24
08714729121206Ultraflex™ Esophageal NGM005142102015-09-24
08714729121213Ultraflex™ Esophageal NGM005142202015-09-24
08714729121220Ultraflex™ Esophageal NGM005142302015-09-24
08714729649113Ultraflex™ Esophageal NGM005137502015-09-24
08714729716075Ultraflex™ Esophageal NGM005138502015-09-24
08714729716082Ultraflex™ Esophageal NGM005138602015-09-24
08714729716099Ultraflex™ Esophageal NGM005138402015-09-24
08714729716105Ultraflex™ Esophageal NGM005142402015-09-24
08714729716112Ultraflex™ Esophageal NGM005142502015-09-24
08714729716129Ultraflex™ Esophageal NGM005137002015-09-24
08714729716136Ultraflex™ Esophageal NGM005137102015-09-24
08714729716143Ultraflex™ Esophageal NGM005137202015-09-24
08714729716150Ultraflex™ Esophageal NGM005137302015-09-24
08714729716167Ultraflex™ Esophageal NGM005137402015-09-24
08714729716174Ultraflex™ Esophageal NGM005138002015-09-24
08714729716181Ultraflex™ Esophageal NGM005138102015-09-24
08714729716198Ultraflex™ Esophageal NGM005138202015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
14042761085172OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085189OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085196OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085202OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085219OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085226OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085233OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085240OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085257OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085264OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085271OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085288OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085295OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085301OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085318OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085325OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31