Uni-Wedge, Regular

GUDID D876938521

The Uni-Wedge is a plastic wedge that is meant to replace standard wooden wedges. The Uni-Wedges are flexible, made of plastic and will not break or splinter. Designed with finder grips to facilitate use. Each box contains 250 wedges.

ALMORE INTERNATIONAL INC

Dental wedge, single-use

• Primary Device ID: D876938521
• NIH Device Record Key: 611c0b13-0581-4d93-a624-b547bae5e0ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Uni-Wedge, Regular
• Version Model Number: 93852
• Company DUNS: 009051723
• Company Name: ALMORE INTERNATIONAL INC
• Device Count: 250
• 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: false
• 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
HIBCC	D876938520 [Unit of Use]
HIBCC	D876938521 [Primary]

FDA Product Code

• EIF: Accessories, Retractor, Dental

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: 2019-08-01
• Device Publish Date: 2019-07-24

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• D876938521 - Uni-Wedge, Regular: 2019-08-01The Uni-Wedge is a plastic wedge that is meant to replace standard wooden wedges. The Uni-Wedges are flexible, made of plastic and will not break or splinter. Designed with finder grips to facilitate use. Each box contains 250 wedges.
• D876938521 - Uni-Wedge, Regular: 2019-08-01 The Uni-Wedge is a plastic wedge that is meant to replace standard wooden wedges. The Uni-Wedges are flexible, made of plastic a