FDA.reportPublic FDA data

superDimension

Primary DI
10884521809574
Brand
superDimension
Company
Covidien LP
Model
SDTNB1000
Device description
Triple Needle Cytology Brush;10 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
20884521809571PackageGS110In Commercial Distribution
10884521809574PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452180957120884521809571
1088452180957410884521809574

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
10884521703827Tri-Staple 2.0SIGCIR21MTORVIL2026-08-09
10884521703834Tri-Staple 2.0SIGCIR21XTORVIL2026-08-09
10884521703841Tri-Staple 2.0SIGCIR25MTORVIL2026-08-09
10884521703858Tri-Staple 2.0SIGCIR25XTORVIL2026-08-09
10884521782648ValleylabE105202021-07-12
10884521703797Tri-Staple 2.0SIGCIR21XT2026-07-31
10884521703810Tri-Staple 2.0SIGCIR25XT2026-07-31
10884521102163Vascufil88864788-05V2015-08-31
10884522006545Shiley10DCFS2015-08-28
10884522030021Shiley5.0 PDL2015-09-15
10884522030083Shiley6.0 PDL2015-09-15
20884522029022Shiley8DCT2015-08-31
20884522029114Shiley4.5PDC2015-10-20
20884522031957Shiley10LPC-S2015-08-28
20884522031964Shiley4LPC-S2015-08-28
20884522031988Shiley8LPC-S2017-05-25
30884522026653Shiley3.0 NEO2015-09-15
30884522026684Shiley4.5 NEO2015-10-12
10884521833869EndoflipEF-301-RFB2024-04-12
10884521855359GI GeniusGGM300-US-RFB2026-07-26

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
10884521809581superDimensionCovidien 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