FDA.reportPublic FDA data

Soft K-Cot(R)

Primary DI
00860275000361
Brand
Soft K-Cot(R)
Company
HISTOLOGICS, LLC
Model
SFT-4200
Device description
The Soft K-Cot(R) is a single-use, nitrile, finger cot, brush/curette, which is placed over an already gloved finger.
Published
2021-07-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZSCurette, Surgical, General Use
GEEBrush, Biopsy, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZSCurette, Surgical, General UseGeneral, Plastic Surgery1
GEEBrush, Biopsy, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860275000368PackageGS1250In Commercial Distribution
00860275000361PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086027500036810860275000368
00860275000361008602750003618602750003610860275000361

GMDN Terms#

Term, Definition table
TermDefinition
Wound debridement padA sterile device intended to be used for the manual debridement of wounds (e.g., diabetic foot ulcers, venous ulcers, arterial ulcers, pressure ulcers, bedsores) by gentle wiping of the wound surface to remove unhealthy tissue (e.g., exudate, slough, cellular debris) to promote healing. It typically consists of a swab-like pad with the side to be used for debridement made of synthetic polymer (e.g., monofilament polyester) fibres. It may be soaked in water/saline before use. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-738-9757Histologics@gmail.com
888-235-2275Support@histologicswc.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
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
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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