Soft K-Rette SFT-4500

GUDID 10860275000351

Wound debridement and tissue sampling device, tapered brush tip for wound tunnels.

HISTOLOGICS, LLC

Wound debridement pad
Primary Device ID10860275000351
NIH Device Record Key529e604b-dce2-4d6a-8222-078a3d2216ab
Commercial Distribution StatusIn Commercial Distribution
Brand NameSoft K-Rette
Version Model NumberSFT-4500
Catalog NumberSFT-4500
Company DUNS023001257
Company NameHISTOLOGICS, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-738-9757
EmailHistologics@gmail.com
Phone888-738-9757
EmailHistologics@gmail.com
Phone888-738-9757
EmailHistologics@gmail.com
Phone888-738-9757
EmailHistologics@gmail.com
Phone888-738-9757
EmailHistologics@gmail.com
Phone888-738-9757
EmailHistologics@gmail.com
Phone888-738-9757
EmailHistologics@gmail.com
Phone888-738-9757
EmailHistologics@gmail.com
Phone888-738-9757
EmailHistologics@gmail.com
Phone888-738-9757
EmailHistologics@gmail.com
Phone888-738-9757
EmailHistologics@gmail.com
Phone888-738-9757
EmailHistologics@gmail.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860275000354 [Primary]
GS110860275000351 [Package]
Contains: 00860275000354
Package: Case [250 Units]
In Commercial Distribution

FDA Product Code

FZSCurette, Surgical, General Use

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-18
Device Publish Date2019-11-10

Devices Manufactured by HISTOLOGICS, LLC

00860275000361 - Soft K-Cot(R)2021-08-02 The Soft K-Cot(R) is a single-use, nitrile, finger cot, brush/curette, which is placed over an already gloved finger.
10860275000313 - SoftBiopsy2019-11-18 Gynecological biopsy device for tissue collection, storage, and transport.
10860275000320 - Soft-ECC2019-11-18 Endocervical curette system for tissue collection, storage, and transport.
10860275000337 - Soft-ECC-S2019-11-18 Endocervical curette system (small size) for tissue collection, storage, and transport.
10860275000344 - Soft K-Bride2019-11-18 Wound debridement and tissue sampling device, trumpet shaped for body surfaces.
10860275000351 - Soft K-Rette2019-11-18Wound debridement and tissue sampling device, tapered brush tip for wound tunnels.
10860275000351 - Soft K-Rette2019-11-18 Wound debridement and tissue sampling device, tapered brush tip for wound tunnels.
00860275000309 - SpiraBrush CX2019-11-11 SpiraBrush CX is intended for obtaining a biopsy of visible exocervical lesions for the purpose of obtaining tissue diagnosis in

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