FDA.reportPublic FDA data

Wallach Endocell

Primary DI
00888937011258
Brand
Wallach Endocell
Company
Coopersurgical, Inc.
Model
908015
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
20888937011252PackageGS135In Commercial Distribution
30888937011259PackageGS1210In Commercial Distribution
00888937011258PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088893701125220888937011252
3088893701125930888937011259
00888937011258008889370112588889370112580888937011258

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
05060488046858EZ-Strip131µm7-72-1131/202025-04-11
05060488046865EZ-Strip135µm7-72-1135/202025-04-11
05060488046872EZ-Strip145µm7-72-1145/202025-04-11
05060488046889EZ-Strip145µm Long7-72-1145L/202025-04-11
05060488046896EZ-Strip155µm7-72-1170/202025-04-11
05060488046902EZ-Strip170µm7-72-1170/202025-04-11
05060488046919EZ-Strip200µm7-72-1290/202025-04-11
05060488046926EZ-Strip290µm7-72-1290/202025-04-11
05060488046933EZ-Strip290µm7-72-1600/202025-04-11
05060488046940EZ-Tip75µm7-72-2075/12025-04-11
05060488046957EZ-Tip125µm7-72-2125/12025-04-11
05060488046964EZ-Tip135µm7-72-2135/12025-04-11
05060488046971EZ-Tip145µm7-72-2145/12025-04-11
05060488046988EZ-Tip155µm7-72-2155/12025-04-11
05060488046995EZ-Tip170µm7-72-2170/12025-04-11
05060488047008EZ-Tip200µm7-72-2200/12025-04-11
05060488047015EZ-Tip250µm7-72-2250/12025-04-11
05060488047022EZ-Tip290µm7-72/2290/12025-04-11
05060488047039EZ-Tip600µm7-72-2600/12025-04-11
05060488047046EZ-Tip75µm7-72-2075/52025-04-11

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
00888937011265Wallach EndocellCoopersurgical, Inc.HFF2016-08-16
00888937011241Wallach EndocellCoopersurgical, Inc.HFF2016-08-16
30888937011259Wallach EndocellCoopersurgical, Inc.HFF2016-08-16
30888937011266Wallach EndocellCoopersurgical, Inc.HFF2016-08-16