Home GUDID 00860275000347 Soft K-Bride
Primary DI 00860275000347
Brand Soft K-Bride
Company HISTOLOGICS, LLC
Model SFT-4000
Catalog number SFT-4000
Device description Wound debridement and tissue sampling device, trumpet shaped for body surfaces.
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 Product Codes# Code, Name table Code Name FZS Curette, Surgical, General Use
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FZS Curette, Surgical, General Use General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10860275000344 Package GS1 250 In Commercial Distribution 00860275000347 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10860275000344 10860275000344 00860275000347 00860275000347 860275000347 0860275000347
GMDN Terms# Term, Definition table Term Definition Manual wound debridement tool A 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.
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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published B382SD9147092060 Surgical Direct Surgical Direct, Inc. FZS 2026-07-09 B382SD9147092120 Surgical Direct Surgical Direct, Inc. FZS 2026-07-09 B382SD9147092130 Surgical Direct Surgical Direct, Inc. FZS 2026-07-09 B382SD9147092140 Surgical Direct Surgical Direct, Inc. FZS 2026-07-09 B382SD9147096450 Surgical Direct Surgical Direct, Inc. FZS 2026-07-09 B382SD9147096460 Surgical Direct Surgical Direct, Inc. FZS 2026-07-09 B382SD9147096470 Surgical Direct Surgical Direct, Inc. FZS 2026-07-09 B382SD9147096510 Surgical Direct Surgical Direct, Inc. FZS 2026-07-09 B382SD9147096520 Surgical Direct Surgical Direct, Inc. FZS 2026-07-09 B382SD9147096530 Surgical Direct Surgical Direct, Inc. FZS 2026-07-09 B382SD9147096540 Surgical Direct Surgical Direct, Inc. FZS 2026-07-09 B382SD9147096550 Surgical Direct Surgical Direct, Inc. FZS 2026-07-09 07640139342119 ROMEO 2 INSTRUMENTATION SpineArt SA FZS 2025-11-10 04046963939588 NOVOCART Aesculap AG FZS 2020-04-24 04046963315511 NOVOCART Aesculap AG FZS 2020-04-23 04046963315528 NOVOCART Aesculap AG FZS 2020-04-23 10649111094002 Sklar SKLAR CORPORATION FZS 2019-08-26 10649111094088 Sklar SKLAR CORPORATION FZS 2019-08-26 10649111217210 Sklar SKLAR CORPORATION FZS 2019-03-15 10649111217494 Sklar SKLAR CORPORATION FZS 2019-03-15 10649111217586 Sklar SKLAR CORPORATION FZS 2019-03-15 10649111217838 Sklar SKLAR CORPORATION FZS 2019-03-15 10649111017711 Sklar SKLAR CORPORATION FZS 2019-03-13 10649111017858 Sklar SKLAR CORPORATION FZS 2019-03-13 10649111018084 Sklar SKLAR CORPORATION FZS 2019-03-13 10649111018282 Sklar SKLAR CORPORATION FZS 2019-03-13 10649111018619 Sklar SKLAR CORPORATION FZS 2019-03-13 10649111161612 Sklar SKLAR CORPORATION FZS 2019-03-13 10649111161964 Sklar SKLAR CORPORATION FZS 2019-03-13 10649111162060 Sklar SKLAR CORPORATION FZS 2019-03-13
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