Primary Device ID | 00860275000361 |
NIH Device Record Key | f78cf2ee-a2b3-48a6-a0a8-d56e9d623253 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Soft K-Cot(R) |
Version Model Number | SFT-4200 |
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 | false |
OTC Over-The-Counter | false |
Phone | 888-738-9757 |
Histologics@gmail.com | |
Phone | 888-738-9757 |
Histologics@gmail.com | |
Phone | 888-738-9757 |
Histologics@gmail.com | |
Phone | 888-738-9757 |
Histologics@gmail.com | |
Phone | 888-738-9757 |
Histologics@gmail.com | |
Phone | 888-738-9757 |
Histologics@gmail.com | |
Phone | 888-738-9757 |
Histologics@gmail.com | |
Phone | 888-738-9757 |
Histologics@gmail.com | |
Phone | 888-738-9757 |
Histologics@gmail.com | |
Phone | 888-738-9757 |
Histologics@gmail.com | |
Phone | 888-738-9757 |
Histologics@gmail.com | |
Phone | 888-738-9757 |
Histologics@gmail.com | |
Phone | 888-738-9757 |
Histologics@gmail.com | |
Phone | 888-738-9757 |
Histologics@gmail.com | |
Phone | 888-738-9757 |
Histologics@gmail.com | |
Phone | 888-738-9757 |
Histologics@gmail.com | |
Phone | 888-738-9757 |
Histologics@gmail.com | |
Phone | 888-738-9757 |
Histologics@gmail.com | |
Phone | 888-738-9757 |
Histologics@gmail.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00860275000361 [Primary] |
GS1 | 10860275000368 [Package] Package: Case [250 Units] In Commercial Distribution |
FZS | Curette, Surgical, General Use |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-08-02 |
Device Publish Date | 2021-07-25 |
00860275000361 - Soft K-Cot(R) | 2021-08-02The Soft K-Cot(R) is a single-use, nitrile, finger cot, brush/curette, which is placed over an already gloved finger. |
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 | 2019-11-18 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 |