FDA.reportPublic FDA data

Uterobrush

Primary DI
00888937003291
Brand
Uterobrush
Company
Coopersurgical, Inc.
Model
E0001
Device description
Endometrial brush
Published
2016-08-25
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

Product Codes#

Code, Name table
CodeName
HFEBrush, Endometrial

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HFEBrush, EndometrialObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K897070000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K897070000ENDOBRUSH(TM) DEVICE; OMNIBRUSHIntl. Cytobrush, Inc.1990-09-10HFE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888937003295PackageGS1500In Commercial Distribution
00888937003291PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088893700329520888937003295
00888937003291008889370032918889370032910888937003291

GMDN Terms#

Term, Definition table
TermDefinition
Endometrial cytology brushA device with bristle-like projections designed to remove samples of the endometrium (the mucosal lining of the uterus) by brushing its interior surface. It is used in the study of endometrial cytology (cells). This is a reusable device.

Regulatory Flags#

DUNS number
801895244
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888937033687ONETRACC1001502026-07-10
00888937033694ONETRACC1001652026-07-10
00888937033700ONETRACC1001702026-07-10
00888937033717ONETRACC1001802026-07-10
00888937033724ONETRACC1001902026-07-10
00888937033731ONETRAC LXC1002102026-07-10
00888937033748ONETRAC LXC1002202026-07-10
00888937033755ONETRAC LXC1002302026-07-10
00888937033762ONETRAC LXC1002402026-07-10
00888937033779ONETRAC LXC1002502026-07-10
00888937033786ONETRAC™ LXSC1002602026-07-10
00888937033793ONETRAC™ LXSC1002702026-07-10
00888937033809ONETRAC™ LXSC1002802026-07-10
00888937033816ONETRAC™ LXSC1002902026-07-10
00888937033823ONETRAC™ LXSC1102002026-07-10
00888937033830ONETRAC™ LXSC1102102026-07-10
00888937033847ONETRAC™ LXSC1102202026-07-10
00888937033854ONETRAC™ LXSC1103102026-07-10
00888937033861ONETRAC™ LXSC1103202026-07-10
00888937033663ONETRAC™C1001102026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00869368000202MatrixBrush Endometrial SamplerPOST OAK INNOVATIONS INCHFE2020-04-23
00827002170230TaoCOOK INCORPORATEDHFE2016-09-24
00827002462489TaoCOOK INCORPORATEDHFE2016-09-24
20888937003295UterobrushCoopersurgical, Inc.HFE2016-08-25