FDA.reportPublic FDA data

Soft K-Rette

Primary DI
10860275000351
Brand
Soft K-Rette
Company
HISTOLOGICS, LLC
Model
SFT-4500
Catalog number
SFT-4500
Device description
Wound debridement and tissue sampling device, tapered brush tip for wound tunnels.
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
FZSCurette, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZSCurette, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860275000351PackageGS1250In Commercial Distribution
00860275000354PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086027500035110860275000351
00860275000354008602750003548602750003540860275000354

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

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
10860275000337Soft-ECC-SSFT-2100SFT-21002019-11-10
10860275000344Soft K-BrideSFT-4000SFT-40002019-11-10
00860275000309SpiraBrush CXSBX-9000SBX-90002016-09-28

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Primary DI, Brand, Company table
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