FDA.reportPublic FDA data

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
00888937027327ER-SpecC0203002026-08-05
00888937027334ER-SpecC0203102026-08-05
00888937027341ER-SpecC0203202026-08-05
00888937027358HER-SpecC0206002026-08-05
00888937027365HER-SpecC0206102026-08-05
00888937027372HER-SpecC0206202026-08-05
00888937027389OfficeSPECC0200012026-08-06
00888937027396HER-SpecC0205002026-08-06
00888937027402HER-SpecC0205102026-08-06
00888937027419HER-SpecC0205202026-08-06
00888937027426ER-SPECC020100-12026-08-06
00888937027433ER-SPECC020110-12026-08-06
00888937027440ER-SpecC020120-12026-08-06
00888937027457ER-SpecC020130-12026-08-06
00888937027464ER-SpecC020140-12026-08-06
00888937027594AnoSPECC0601002026-08-05
00888937027600AnoSPECC0601102026-08-05
00888937027617AnoSPECC0601202026-08-05
00888937032833LifeGlobal® Coda®Incubator UnitGCIU-010-M2026-08-03
00888937032840LifeGlobal® Coda®Filter for Incubator UnitGCIF-001-M2026-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD9150991000Surgical DirectSurgical Direct, Inc.PCF2026-07-28
B382SD91553010100Surgical DirectSurgical Direct, Inc.PCF2026-07-28
B382SD91553010110Surgical DirectSurgical Direct, Inc.PCF2026-07-28
B382SD9155301040Surgical DirectSurgical Direct, Inc.PCF2026-07-28
B382SD9155301050Surgical DirectSurgical Direct, Inc.PCF2026-07-28
B382SD9155301060Surgical DirectSurgical Direct, Inc.PCF2026-07-28
B382SD9155301080Surgical DirectSurgical Direct, Inc.PCF2026-07-28
B382SD915580100Surgical DirectSurgical Direct, Inc.PCF2026-07-28
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