Treo

GUDID 10366975000665

Treo Pouch, 3.5 x 5.25

BENCO DENTAL SUPPLY CO.

Sterilization packaging, single-use

• Primary Device ID: 10366975000665
• NIH Device Record Key: a7162010-73bc-4427-bcd2-cced43f55b41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Treo
• Version Model Number: 4224-644
• Company DUNS: 015108087
• Company Name: BENCO DENTAL SUPPLY CO.
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00366975000668 [Primary]
GS1	10366975000665 [Package]; Contains: 00366975000668; Package: Case [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K941327

FDA Product Code

• KCT: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-09-23

On-Brand Devices [Treo]

• 10366975000702: Treo Pouch 7.5 x 13
• 10366975000696: Treo Pouch, 5.25 x 10
• 10366975000689: Treo Pouch, 3.5 x 9
• 10366975000672: Treo Pouch, 2.75 x 9
• 10366975000665: Treo Pouch, 3.5 x 5.25