FDA.reportPublic FDA data

Cytosponge

Primary DI
20884521767789
Brand
Cytosponge
Company
Covidien LP
Model
CYTO-201
Device description
Cell Collection Device
Published
2021-11-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EOXEsophagoscope (flexible or rigid)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOXEsophagoscope (Flexible Or Rigid)Ear, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181020000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181020000Cytosponge Cell Collection DeviceCovidien, LLC2018-08-16EOX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521767789PrimaryGS10
10884521767782Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452176778920884521767789
1088452176778210884521767782

GMDN Terms#

Term, Definition table
TermDefinition
Cytology scraper, single-useA wooden, plastic, or metal instrument used to collect a scraping of cells from tissue for the purposes of a diagnostic examination. This is a single-use device.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
058614483
Device count
20
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521620193Shiley18775S2017-04-18
10884521620209Shiley18780S2017-01-06
10884521543805SigniaSIGADAPTSTND2017-08-08
10884521824355McGRATHX3-003-0002021-09-01
10884521032903BiosynGMT-2262015-09-01
10884521073517VersaportNBFCA5ST2016-09-24
10884521085329SofsilkGSJ-36-M2015-09-01
10884521085336SofsilkGSJ-37-M2015-09-01
10884521101999Vascufil88864722-21V2015-08-31
10884521191013Endo GIAEGIATRS60AMT2015-09-01
10884521543522Tri-Staple 2.0SIGC60VT2017-05-26
10884521543638Tri-Staple 2.0SIGTRS60AMT2017-05-26
10884521726352ReliaTackRELTACK8RDPTSW2018-06-03
10884523000627SILSSILSHOOK362016-09-24
10884523000917Surgiwand II1780942016-09-24
10884523006599Premium Plus CEEA1119852015-08-28
10884524001500ValleylabE2516HS2016-09-24
10884521195202SonicisionSCD132018-08-10
10884521807884SonicisionSCD132020-06-29
10884521546219LigaSureLIGASUREZD2018-09-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04961333251766PENTAX MedicalHOYA CORPORATIONEOX2023-06-21
00860008795557EsoCheck CCD Cell Collection DeviceLucid Diagnostics IncEOX2023-01-26
04048551417348n.a.Karl Storz GmbH & Co. KGEOX2020-03-02
00860002356006EsoCheck CCD Cell Collection DeviceLucid Diagnostics IncEOX2019-12-17
00874485003210UNITY 9100COGENTIX MEDICAL, INC.EOX2018-12-20
04048551178515n.a.Karl Storz GmbH & Co. KGEOX2018-07-21
04048551178539n.a.Karl Storz GmbH & Co. KGEOX2018-07-21
04048551178546n.a.Karl Storz GmbH & Co. KGEOX2018-07-21
04048551190098n.a.Karl Storz GmbH & Co. KGEOX2018-07-21
04048551190104n.a.Karl Storz GmbH & Co. KGEOX2018-07-21
04048551190111n.a.Karl Storz GmbH & Co. KGEOX2018-07-21
00874485002985EndoSheath TechnologyCOGENTIX MEDICAL, INC.EOX2016-09-23
00874485003005EndoSheath TechnologyCOGENTIX MEDICAL, INC.EOX2016-09-23
04048551001387n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551001493n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551001974n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047675n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047811n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047828n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047866n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047873n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047897n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047903n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047941n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047989n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047996n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551048641n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551048658n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551053591n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551068762n.a.Karl Storz GmbH & Co. KGEOX2016-09-23