3.5" X 6.5" PRACTICON STERILIZATION POUCHES 7158233

GUDID 00723896026373

Self-Sealing sterilization pouches with internal and external indicators. 200 per box

PRACTICON, INC.

Sterilization packaging, single-use

• Primary Device ID: 00723896026373
• NIH Device Record Key: 50f59a8c-5d80-454a-a440-e3eb8fa1b567
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3.5" X 6.5" PRACTICON STERILIZATION POUCHES
• Version Model Number: 7158233
• Catalog Number: 7158233
• Company DUNS: 119193803
• Company Name: PRACTICON, 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: true
• 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	00723896026366 [Primary]
GS1	00723896026373 [Package]; Contains: 00723896026366; Package: CASE [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162258

FDA Product Code

• FRG: Wrap, Sterilization

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-15
• Device Publish Date: 2024-08-07

Devices Manufactured by PRACTICON, INC.

• 00723896029855 - Practicon Color Splash™ Saliva Ejectors 100/Pack: 2026-01-16 Saliva ejector used to clear water from the mouth during dental procedures. Assorted green, pink, purple, and blue opaque vinyl.
• 00723896029886 - Practicon Bliss™ Level 3 Face Mask 50/Box Black: 2026-01-16 Soft level 3 face mask with extra soft ear loops for comfort. 50 per box
• 00723896029916 - Practicon Bliss™ Level 3 Face Mask 50/Box Blue: 2026-01-16 Soft level 3 face mask with extra soft ear loops for comfort. 50 per box
• 00723896030295 - ECOsply™ Biodegradable Disposable Impression Trays Large Upper 10/Pack: 2026-01-16 Single use impression trays used to take a impression of a patients mouth in a dental setting. 10 per bag
• 00723896030325 - ECOsply™ Biodegradable Disposable Impression Trays Large Lower 10/Pack: 2026-01-16 Single use impression trays used to take a impression of a patients mouth in a dental setting. 10 per bag
• 00723896030356 - ECOsply™ Biodegradable Disposable Impression Trays Medium Upper 10/Pack: 2026-01-16 Single use impression trays used to take a impression of a patients mouth in a dental setting. 10 per bag
• 00723896030387 - ECOsply™ Biodegradable Disposable Impression Trays Medium Lower 10/Pack: 2026-01-16 Single use impression trays used to take a impression of a patients mouth in a dental setting. 10 per bag
• 00723896030417 - ECOsply™ Biodegradable Disposable Impression Trays Small Upper 10/Pack: 2026-01-16 Single use impression trays used to take a impression of a patients mouth in a dental setting. 10 per bag