FDA.reportPublic FDA data

Wallach Endocell

Primary DI
00888937011265
Brand
Wallach Endocell
Company
Coopersurgical, Inc.
Model
908016
Device description
Endometrial Cell Sampler
Published
2016-08-16
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

Product Codes#

Code, Name table
CodeName
HFFAspirator, Endometrial

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K902693000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K902693000WALLACH FLEXIBLE ENDOMETRIAL SAMPLERWallach Surgical Devices, Inc.1991-01-31HFF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888937011269PackageGS135In Commercial Distribution
30888937011266PackageGS1525In Commercial Distribution
00888937011265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088893701126920888937011269
3088893701126630888937011266
00888937011265008889370112658889370112650888937011265

GMDN Terms#

Term, Definition table
TermDefinition
Endometrial biopsy kitA collection of sterile devices designed for the collection of a tissue sample taken from the lining of the uterus (endometrium). It typically includes an aspirating curette, a specimen container and other materials. It is used in the study of endometrial cytology (cells). This is a single-use device.

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
00853277008084LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)UVISION 360, INC.HFF2021-08-13
00853277008091LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)UVISION 360, INC.HFF2021-08-13
05425017500032EchosamplerGynetics Medical Products NVHFF2017-01-17
25425017500036EchosamplerGynetics Medical Products NVHFF2017-01-17
05425017500377GynosamplerGynetics Medical Products NVHFF2016-10-04
00827002461901GoldsteinCOOK INCORPORATEDHFF2016-09-24
10827002461908GoldsteinCOOK INCORPORATEDHFF2016-09-24
10805360016831GynosamplerVITROLIFE INC.HFF2016-09-23
00888937011258Wallach EndocellCoopersurgical, Inc.HFF2016-08-16
00888937011241Wallach EndocellCoopersurgical, Inc.HFF2016-08-16
30888937011259Wallach EndocellCoopersurgical, Inc.HFF2016-08-16
30888937011266Wallach EndocellCoopersurgical, Inc.HFF2016-08-16