FDA.reportPublic FDA data

Soft-ECC-S

Primary DI
00860275000330
Brand
Soft-ECC-S
Company
HISTOLOGICS, LLC
Model
SFT-2100
Catalog number
SFT-2100
Device description
Endocervical curette system (small size) 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
10860275000337PackageGS1250In Commercial Distribution
00860275000330PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086027500033710860275000337
00860275000330008602750003308602750003300860275000330

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
00860275000323Soft-ECCSFT-2000SFT-20002019-11-10
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

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Primary DI, Brand, Company table
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