FDA.reportPublic FDA data

Wallach Endocell

Primary DI
30888937011259
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
OTC
false
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
801895244
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00888937011258Wallach EndocellCoopersurgical, Inc.HFF2016-08-16
00888937011265Wallach EndocellCoopersurgical, Inc.HFF2016-08-16
00888937011241Wallach EndocellCoopersurgical, Inc.HFF2016-08-16
30888937011266Wallach EndocellCoopersurgical, Inc.HFF2016-08-16