SoftBiopsy SFT-1000

GUDID 10860275000313

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

HISTOLOGICS, LLC

Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush 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