Cytology Brush

GUDID 00813360023035

8" Cytology Brush

TEAM TECHNOLOGIES, INC.

Cervical cytology scraper, single-use Cervical cytology scraper, single-use

• Primary Device ID: 00813360023035
• NIH Device Record Key: 6a4c6f68-cdfb-42b7-acc8-ee8ddb8c949c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cytology Brush
• Version Model Number: 1
• Company DUNS: 078550672
• Company Name: TEAM TECHNOLOGIES, INC.
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813360023035 [Primary]
GS1	10813360023032 [Package]; Package: Bag [1000 Units]; In Commercial Distribution
GS1	20813360023039 [Package]; Contains: 10813360023032; Package: Inner Box [1000 Units]; In Commercial Distribution
GS1	30813360023036 [Package]; Contains: 20813360023039; Package: Case [6000 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K971849

FDA Product Code

• HHT: Spatula, Cervical, Cytological

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-11
• Device Publish Date: 2016-09-21

On-Brand Devices [Cytology Brush]

• 00813360023035: 8" Cytology Brush
• 00813360023011: 8" Cytology Brush