FDA.reportPublic FDA data

superDimension

Primary DI
10884521809581
Brand
superDimension
Company
Covidien LP
Model
SDTNB1500
Device description
Triple Needle Cytology Brush;15 mm
Published
2020-10-16
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTGBrush, biopsy, bronchoscope (non-rigid)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTGBrush, Biopsy, Bronchoscope (Non-Rigid)Ear, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521809588PackageGS110In Commercial Distribution
10884521809581PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452180958820884521809588
1088452180958110884521809581

GMDN Terms#

Term, Definition table
TermDefinition
Flexible endoscopic cytology brush, single-useA device intended to be used in combination with a compatible flexible endoscope to collect cells of the mucosa for pathological diagnosis during endoscopy. It is inserted through the working channel of the endoscope and consists of a flexible insertion portion made of a metal coil or plastic tube, whose distal end is equipped with plastic bristles for harvesting mucosal cells, e.g., during bronchoscopy. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length115Centimeter
Outer Diameter1.9Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521072602V-LocVLOCN204L2015-09-02
20884521126852Sofsilk1700022016-09-24
10884521091986NellcorSC-A-I2026-05-25
10884521758803Vascufil8886470311V-22020-07-19
10884521816312McGRATH MAC350-005-0002021-10-21
10884521816329McGRATH MAC350-013-0002021-08-30
10884521816336McGRATH MAC350-017-0002021-10-18
10884521816343McGRATH MAC350-072-0002022-06-13
10884521824317McGRATH MAC350-005-0002022-09-25
10884521824324McGRATH MAC350-013-0002021-10-30
10884521824331McGRATH MAC350-017-0002021-08-26
10884521824348McGRATH MAC350-072-0002023-06-19
10884521850118McGRATH MAC350-005-0002025-04-27
10884521850125McGRATH MAC350-013-0002025-04-27
10884521850132McGRATH MAC350-017-0002025-04-27
10884521850149McGRATH MAC350-072-0002025-04-27
15060272980310McGRATH MAC350-005-0002021-08-02
15060272980327McGRATH MAC350-013-0002022-01-17
15060272980334McGRATH MAC350-072-0002021-04-18
15060272980341McGRATH MAC350-017-0002021-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04953170466724DISPOSABLE CYTOLOGY BRUSHOLYMPUS MEDICAL SYSTEMS CORP.BTG2025-07-04
04953170466731DISPOSABLE CYTOLOGY BRUSHOLYMPUS MEDICAL SYSTEMS CORP.BTG2025-07-04
04953170466748DISPOSABLE CYTOLOGY BRUSHOLYMPUS MEDICAL SYSTEMS CORP.BTG2025-07-04
04953170466755DISPOSABLE CYTOLOGY BRUSHOLYMPUS MEDICAL SYSTEMS CORP.BTG2025-07-04
04953170465987DISPOSABLE CYTOLOGY BRUSHOLYMPUS MEDICAL SYSTEMS CORP.BTG2025-06-20
04953170465994DISPOSABLE CYTOLOGY BRUSHOLYMPUS MEDICAL SYSTEMS CORP.BTG2025-06-20
04953170466007DISPOSABLE CYTOLOGY BRUSHOLYMPUS MEDICAL SYSTEMS CORP.BTG2025-06-20
04953170466014DISPOSABLE CYTOLOGY BRUSHOLYMPUS MEDICAL SYSTEMS CORP.BTG2025-06-20
04953170466021DISPOSABLE CYTOLOGY BRUSHOLYMPUS MEDICAL SYSTEMS CORP.BTG2025-06-20
14953170465984DISPOSABLE CYTOLOGY BRUSHOLYMPUS MEDICAL SYSTEMS CORP.BTG2025-06-20
14953170465991DISPOSABLE CYTOLOGY BRUSHOLYMPUS MEDICAL SYSTEMS CORP.BTG2025-06-20
14953170466004DISPOSABLE CYTOLOGY BRUSHOLYMPUS MEDICAL SYSTEMS CORP.BTG2025-06-20
14953170466011DISPOSABLE CYTOLOGY BRUSHOLYMPUS MEDICAL SYSTEMS CORP.BTG2025-06-20
14953170466028DISPOSABLE CYTOLOGY BRUSHOLYMPUS MEDICAL SYSTEMS CORP.BTG2025-06-20
04953170409011Single Use Guide Sheath KitOLYMPUS MEDICAL SYSTEMS CORP.BTG2021-11-15
04953170408984Single Use Guide Sheath KitOLYMPUS MEDICAL SYSTEMS CORP.BTG2021-11-05
04953170406171Single Use Guiding DeviceOLYMPUS MEDICAL SYSTEMS CORP.BTG2021-09-07
14953170406178Single Use Guiding DeviceOLYMPUS MEDICAL SYSTEMS CORP.BTG2021-09-07
10884521809574superDimensionCovidien LPBTG2020-10-16
20884521809571superDimensionCovidien LPBTG2020-10-16
20884521809588superDimensionCovidien LPBTG2020-10-16
04953170401961Single Use Cytology Brush BC-205DOLYMPUS MEDICAL SYSTEMS CORP.BTG2019-08-19
14953170401968Single Use Cytology Brush BC-205DOLYMPUS MEDICAL SYSTEMS CORP.BTG2019-08-19
08714729746232CellebrityBOSTON SCIENTIFIC CORPORATIONBTG2016-09-24
08714729746249CellebrityBOSTON SCIENTIFIC CORPORATIONBTG2016-09-24
08714729746300CellebrityBOSTON SCIENTIFIC CORPORATIONBTG2016-09-24
08714729746331CellebrityBOSTON SCIENTIFIC CORPORATIONBTG2016-09-24
10653405052340CONMEDConmed CorporationBTG2016-09-24
10884521200548superDimensionCovidien LPBTG2016-09-24
10884521200555superDimensionCovidien LPBTG2016-09-24