6.5" Cytology Brush

GUDID 50813360023023

TEAM TECHNOLOGIES, INC.

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

• Primary Device ID: 50813360023023
• NIH Device Record Key: 9eae2246-b9d1-41e3-a3f0-65edd1559c22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 6.5" 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: false
• 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	00813360023028 [Primary]
GS1	10813360023025 [Package]; Contains: 00813360023028; Package: Bag [100 Units]; In Commercial Distribution
GS1	20813360023022 [Package]; Contains: 10813360023025; Package: Inner [1000 Units]; In Commercial Distribution
GS1	30813360023029 [Package]; Contains: 10813360023025; Package: Case [3000 Units]; In Commercial Distribution
GS1	40813360023026 [Package]; Contains: 20813360023022; Package: Case [6000 Units]; In Commercial Distribution
GS1	50813360023023 [Package]; Contains: 00813360023028; Package: Case [3000 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: 2016-08-16

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