PeriAcryl

GUDID D7950000021

Glustich Inc

Clinical periodontal dressing Clinical periodontal dressing

• Primary Device ID: D7950000021
• NIH Device Record Key: b6423629-b38c-4220-b2e8-004721098e5f
• Commercial Distribution Discontinuation: 2019-03-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: PeriAcryl
• Version Model Number: P-ACRYLU(V)
• Company DUNS: 201637158
• Company Name: Glustich 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7950000010 [Primary]
HIBCC	D7950000021 [Package]; Contains: D7950000010; Package: BOX [12 Units]; Discontinued: 2019-03-01; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071484

FDA Product Code

• EMA: Cement, Dental

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-03-01
• Device Publish Date: 2017-02-13

On-Brand Devices [PeriAcryl]

• D7950000050: P-ACRYLU(V)HV
• D7950000041: P-ACRYLU(C)
• D7950000021: P-ACRYLU(V)