SoftBiopsy SFT-1000

GUDID 10860275000313

Gynecological biopsy device for tissue collection, storage, and transport.

HISTOLOGICS, LLC

Cervical cytology brush

• Primary Device ID: 10860275000313
• NIH Device Record Key: b81e7db9-14be-451e-84ee-ffa9bcdc9cf6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SoftBiopsy
• Version Model Number: SFT-1000
• Catalog Number: SFT-1000
• 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

Customer Support Contacts

• Phone: 888-738-9757
• Email: Histologics@gmail.com
• Phone: 888-738-9757
• Email: Histologics@gmail.com
• Phone: 888-738-9757
• Email: Histologics@gmail.com
• Phone: 888-738-9757
• Email: Histologics@gmail.com
• Phone: 888-738-9757
• Email: Histologics@gmail.com
• Phone: 888-738-9757
• Email: Histologics@gmail.com
• Phone: 888-738-9757
• Email: Histologics@gmail.com
• Phone: 888-738-9757
• Email: Histologics@gmail.com
• Phone: 888-738-9757
• Email: Histologics@gmail.com
• Phone: 888-738-9757
• Email: Histologics@gmail.com
• Phone: 888-738-9757
• Email: Histologics@gmail.com
• Phone: 888-738-9757
• Email: Histologics@gmail.com
• Phone: 888-738-9757
• Email: Histologics@gmail.com
• Phone: 888-738-9757
• Email: Histologics@gmail.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860275000316 [Primary]
GS1	10860275000313 [Package]; Contains: 00860275000316; Package: Case [250 Units]; In Commercial Distribution

FDA Product Code

• HFB: Forceps, Biopsy, Gynecological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-18
• Device Publish Date: 2019-11-10

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 - SoftBiopsy: 2019-11-18Gynecological biopsy device for tissue collection, storage, and transport.
• 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