SpiraBrush CX SBX-9000

GUDID 00860275000309

SpiraBrush CX is intended for obtaining a biopsy of visible exocervical lesions for the purpose of obtaining tissue diagnosis in women with intraepithelial disease.

HISTOLOGICS, LLC

Cervical cytology scraper, single-use

• Primary Device ID: 00860275000309
• NIH Device Record Key: 1c44b40c-03f0-4a88-910e-55438bdb76fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpiraBrush CX
• Version Model Number: SBX-9000
• Catalog Number: SBX-9000
• Company DUNS: 023001257
• Company Name: HISTOLOGICS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860275000309 [Primary]
GS1	10860275000306 [Package]; Package: Case [250 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011488

FDA Product Code

• HFB: Forceps, Biopsy, Gynecological

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-11
• Device Publish Date: 2016-09-28

Devices Manufactured by HISTOLOGICS, LLC

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• 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: 2019-11-11SpiraBrush CX is intended for obtaining a biopsy of visible exocervical lesions for the purpose of obtaining tissue diagnosis in women with intraepithelial disease.
• 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