Kevor-Curette

Primary DI
00888937003253
Brand
Kevor-Curette
Company
Coopersurgical, Inc.
Model
66-448B
Device description
Disposable Endocervical Curette
Published
2016-09-20
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
PCFSampler, Endocervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PCFSampler, EndocervicalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K882404000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K882404000KEVOR-CURETTEEuro-Med Intl.1988-07-08PCF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888937003257PackageGS125In Commercial Distribution
00888937003253PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088893700325720888937003257
00888937003253008889370032538889370032530888937003253

GMDN Terms#

Term, Definition table
TermDefinition
Endocervical aspiratorA collection of devices designed to remove superficial tissue from the mucous membrane lining the cervical canal (endometrium) through manually-powered suction. It typically includes a slender endocervical curette, a syringe, a bulb, and a pipette. The device is used in obstetrics, gynaecology, surgery, oncology, histology, fertility studies, and cancer screening (cervical carcinoma); it is also used after colposcopy and to aid fertility by removing the mucus plug from the cervix.

Regulatory Flags#

DUNS number
801895244
Device count
1
Lot or batch
true
Expiration date on label
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
20859500005053FemCervFEMASYS INC.PCF2022-09-21
20859500005060FemCervFEMASYS INC.PCF2022-09-21
30859500005050FemCervFEMASYS INC.PCF2022-09-21
30859500005067FemCervFEMASYS INC.PCF2022-09-21
10859500005056FemCervFEMASYS INC.PCF2022-09-21
10859500005063FemCervFEMASYS INC.PCF2022-09-21
00859500005059FemCervFEMASYS INC.PCF2022-09-21
00859500005066FemCervFEMASYS INC.PCF2022-09-21
20888937003257Kevor-CuretteCoopersurgical, Inc.PCF2016-09-20