FDA.reportPublic FDA data

NA

Primary DI
08714729469766
Brand
NA
Company
BOSTON SCIENTIFIC CORPORATION
Model
M006550310
Catalog number
M006550310
Device description
Adapter for Storz Hysteroscope
Published
2018-05-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NWWHysteroscope accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWWHysteroscope AccessoriesObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729469766PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729469766087147294697668714729469766

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
021717889
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191506062514Navigator™M0062504000M00625040002026-09-25
00191506062521Navigator™M0062504010M00625040102026-09-25
00191506062538Navigator™M0062504020M00625040202026-09-25
00191506062545Navigator™M0062504100M00625041002026-09-25
00191506062552Navigator™M0062504110M00625041102026-09-25
00191506062569Navigator™M0062504120M00625041202026-09-25
00191506062576Navigator™M0062504200M00625042002026-09-25
00191506062583Navigator™M0062504210M00625042102026-09-25
00191506062590Navigator™M0062504220M00625042202026-09-25
00802526531101ENDOTAK RELIANCE® S013701372014-09-24
00802526531118ENDOTAK RELIANCE® S013801382014-09-24
00802526531125ENDOTAK RELIANCE®015701572014-09-24
00802526531132ENDOTAK RELIANCE®015801582014-09-24
00191506047832NAM001AJAEC0100M001AJAEC01002026-09-22
00191506063214OPAL HDx™M004OPAL11020M004OPAL110202026-09-20
08714729972860LumiCoil™M005538302018-02-15
08714729972884LumiCoil™M005538402018-02-15
08714729842088Rhythmia™ Mapping SystemM004RH200002017-06-14
08714729842095Rhythmia™ Mapping SystemM004RH210002017-06-14
08714729842101Rhythmia™ Mapping SystemM004RH220002017-06-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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05708265017904LiNA OperaScopeTM LassoLiNA Medical AGNWW2026-04-03
05708265017928LiNA OperaScope Angled LassoLiNA Medical AGNWW2026-04-03
05708265017942LiNA OperaScope Angled LassoLiNA Medical AGNWW2026-04-03
05708265017980LiNA OperaScope™ ScissorsLiNA Medical AGNWW2026-04-03
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