Sycamore Wood Wedges

GUDID 00348783004861

WEDGE BOX OF 400 - 13XT

PREMIER DENTAL PRODUCTS COMPANY

Dental wedge, single-use

• Primary Device ID: 00348783004861
• NIH Device Record Key: 8f2dc3e5-c163-4bc0-b561-9f88bdcd6de6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sycamore Wood Wedges
• Version Model Number: 9061100
• Company DUNS: 014789663
• Company Name: PREMIER DENTAL PRODUCTS COMPANY
• Device Count: 4
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00348783004861 [Unit of Use]
GS1	00348783005042 [Primary]

FDA Product Code

• JEP: Retainer, Matrix

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: 2024-08-14
• Device Publish Date: 2024-08-06

On-Brand Devices [Sycamore Wood Wedges]

• 00348783005103: WEDGE BOX OF 400 ASSORTED (13T, 13, 15, UT)
• 00348783004922: WEDGE BOX OF 400 ULTRA THINS
• 00348783004939: WEDGE BOX OF 400 MINI
• 00348783004915: WEDGE BOX OF 400 - 17
• 00348783004908: WEDGE BOX OF 400 - 16
• 00348783004892: WEDGE BOX OF 400 - 15
• 00348783004861: WEDGE BOX OF 400 - 13XT
• 00348783004878: WEDGE BOX OF 400 - 13T
• 00348783004885: WEDGE BOX OF 400 - 13