| 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 |
| Phone | 888-235-2275 |
| Support@histologicswc.com | |
| Phone | 888-235-2275 |
| Support@histologicswc.com | |
| Phone | 888-235-2275 |
| Support@histologicswc.com | |
| Phone | 888-235-2275 |
| Support@histologicswc.com | |
| Phone | 888-235-2275 |
| Support@histologicswc.com | |
| Phone | 888-235-2275 |
| Support@histologicswc.com | |
| Phone | 888-235-2275 |
| Support@histologicswc.com | |
| Phone | 888-235-2275 |
| Support@histologicswc.com | |
| Phone | 888-235-2275 |
| Support@histologicswc.com | |
| Phone | 888-235-2275 |
| Support@histologicswc.com | |
| Phone | 888-235-2275 |
| Support@histologicswc.com | |
| Phone | 888-235-2275 |
| Support@histologicswc.com |
| 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 |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-11-18 |
| Device Publish Date | 2019-11-10 |
| 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 |