FDA.reportPublic FDA data

Soft K-Rette

Primary DI
00860275000354
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
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
Manual wound debridement toolA 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 is available in a variety of forms (e.g., a swab-like pad with a handle, a thimble-like device worn on the end of a finger); the surface used for debridement is typically made of synthetic polymer. This is a single-use device.

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
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
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
00840314270290gSourceGSOURCE LLCFZS2026-08-07
00810143906592SURGIPROSSurgipros, LLCFZS2026-07-30
00810143906608SURGIPROSSurgipros, LLCFZS2026-07-30
00810143909777SURGIPROSSurgipros, LLCFZS2026-07-30
00810143909784SURGIPROSSurgipros, LLCFZS2026-07-30
00810143909807SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934136SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934143SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934150SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934167SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934174SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934181SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934198SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934204SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934211SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934228SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934235SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934242SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934259SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934266SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934273SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934280SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934297SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934303SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934310SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934327SURGIPROSSurgipros, LLCFZS2026-07-30
07640221373717SCALASpineArt SAFZS2026-07-24
07640221373724SCALASpineArt SAFZS2026-07-24
07640221373731SCALASpineArt SAFZS2026-07-24
07640221373748SCALASpineArt SAFZS2026-07-24