Soft-ECC-S

Primary DI
10860275000337
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
OTC
false
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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
023001257
Device count
1
DM exempt
false
Premarket exempt
true
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
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
00860275000330Soft-ECC-SSFT-2100SFT-21002019-11-10
10860275000313SoftBiopsySFT-1000SFT-10002019-11-10
10860275000320Soft-ECCSFT-2000SFT-20002019-11-10
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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