Soft K-Bride SFT-4000

GUDID 10860275000344

Wound debridement pad

Primary Device ID	10860275000344
NIH Device Record Key	b145475f-a5ec-40b4-bda4-3c8b62f1714c
Commercial Distribution Status	In Commercial Distribution
Brand Name	Soft K-Bride
Version Model Number	SFT-4000
Catalog Number	SFT-4000
Company DUNS	023001257
Company Name	HISTOLOGICS, LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00860275000347 [Primary]
GS1	10860275000344 [Package] Contains: 00860275000347 Package: Case [250 Units] In Commercial Distribution

FZS	Curette, Surgical, General Use

Steralize Prior To Use	false
Device Is Sterile	true

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 - SoftBiopsy	2019-11-18 Gynecological biopsy device for tissue collection, storage, and transport.
10860275000320 - Soft-ECC	2019-11-18 Endocervical curette system for tissue collection, storage, and transport.
10860275000337 - Soft-ECC-S	2019-11-18 Endocervical curette system (small size) for tissue collection, storage, and transport.
10860275000344 - Soft K-Bride	2019-11-18Wound debridement and tissue sampling device, trumpet shaped for body surfaces.
10860275000344 - Soft K-Bride	2019-11-18 Wound debridement and tissue sampling device, trumpet shaped for body surfaces.
10860275000351 - Soft K-Rette	2019-11-18 Wound debridement and tissue sampling device, tapered brush tip for wound tunnels.
00860275000309 - SpiraBrush CX	2019-11-11 SpiraBrush CX is intended for obtaining a biopsy of visible exocervical lesions for the purpose of obtaining tissue diagnosis in