FDA.reportPublic FDA data

Soft-ECC

Primary DI
00860275000323
Brand
Soft-ECC
Company
HISTOLOGICS, LLC
Model
SFT-2000
Catalog number
SFT-2000
Device description
Endocervical curette system for tissue collection, storage, and transport.
Published
2019-11-10
Public version status
New
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
HCYCurette, Uterine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCYCurette, UterineObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860275000320PackageGS1250In Commercial Distribution
00860275000323PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086027500032010860275000320
00860275000323008602750003238602750003230860275000323

GMDN Terms#

Term, Definition table
TermDefinition
Endocervical specimen collection kitA collection of devices intended to be used for the collection, preservation, and transport of cellular and/or other material collected from the endocervix for culture, analysis, and/or other investigation. It typically includes a swab, brush, spatula, and/or other collection devices and a transport container (with or without additives). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
888-738-9757Histologics@gmail.com

Regulatory Flags#

DUNS number
023001257
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860275000347Soft K-BrideSFT-4000SFT-40002019-11-10
00860275000354Soft K-RetteSFT-4500SFT-45002019-11-10
00860275000361Soft K-Cot(R)SFT-42002021-07-25
00860275000316SoftBiopsySFT-1000SFT-10002019-11-10
00860275000330Soft-ECC-SSFT-2100SFT-21002019-11-10
10860275000313SoftBiopsySFT-1000SFT-10002019-11-10
10860275000320Soft-ECCSFT-2000SFT-20002019-11-10
10860275000337Soft-ECC-SSFT-2100SFT-21002019-11-10
10860275000344Soft K-BrideSFT-4000SFT-40002019-11-10
10860275000351Soft K-RetteSFT-4500SFT-45002019-11-10
00860275000309SpiraBrush CXSBX-9000SBX-90002016-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956366428CARDINAL HEALTHCardinal Health 200, LLCHCY2026-06-01
10198956476530CARDINAL HEALTHCardinal Health 200, LLCHCY2026-06-01
07898506815111QuinelatoSchobell Industrial LtdaHCY2023-01-09
07898506815135QuinelatoSchobell Industrial LtdaHCY2023-01-09
07898506815159QuinelatoSchobell Industrial LtdaHCY2023-01-09
07898506815319QuinelatoSchobell Industrial LtdaHCY2023-01-09
07898506815333QuinelatoSchobell Industrial LtdaHCY2023-01-09
07898506815340QuinelatoSchobell Industrial LtdaHCY2023-01-09
07898506815357QuinelatoSchobell Industrial LtdaHCY2023-01-09
07898506815364QuinelatoSchobell Industrial LtdaHCY2023-01-09
07898506840922QuinelatoSchobell Industrial LtdaHCY2023-01-09
10195594752279CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-26
10195594758813CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-25
10195594745776CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-18
10195594754730CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-15
10195594684549CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-14
10195594758981CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-14
10195594759452CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-14
10195594750367CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-12
10195594685485CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-08
10195594735142CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-07
10195594727260CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-06
10195594727314CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-06
10195594740702CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-06
10195594745981CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-06
10195594623807CARDINAL HEALTHCardinal Health 200, LLCHCY2022-06-24
10195594715830CARDINAL HEALTHCardinal Health 200, LLCHCY2022-06-23
10195594717186CARDINAL HEALTHCardinal Health 200, LLCHCY2022-06-23
10195594727680CARDINAL HEALTHCardinal Health 200, LLCHCY2022-06-23
10195594730994CARDINAL HEALTHCardinal Health 200, LLCHCY2022-06-23