PeriAcryl® P-ACRYLU(V)

GUDID D795013

PeriAcryl® is indicated to be used as an adjunct to temporarily assist in securing periodontal dressings.

Glustich Inc

Clinical periodontal dressing Clinical periodontal dressing

• Primary Device ID: D795013
• NIH Device Record Key: 99ed951b-c835-4c63-9ac8-9dff525ae5de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PeriAcryl®
• Version Model Number: P-ACRYLU(V)
• Catalog 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	D795010 [Primary]
HIBCC	D795013 [Package]; Contains: D795010; Package: BOX [12 Units]; 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: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-06

On-Brand Devices [PeriAcryl®]

• D795101: PeriAcryl® is indicated to be used as an adjunct to temporarily assist in securing periodontal
• D795091: PeriAcryl® is indicated to be used as an adjunct to temporarily assist in securing periodontal
• D795081: PeriAcryl® is indicated to be used as an adjunct to temporarily assist in securing periodontal
• D795071: PeriAcryl® is indicated to be used as an adjunct to temporarily assist in securing periodontal
• D795061: PeriAcryl® is indicated to be used as an adjunct to temporarily assist in securing periodontal
• D795051: PeriAcryl® is indicated to be used as an adjunct to temporarily assist in securing periodontal
• D795041: PeriAcryl® is indicated to be used as an adjunct to temporarily assist in securing periodontal
• D795033: PeriAcryl® is indicated to be used as an adjunct to temporarily assist in securing periodontal
• D795023: PeriAcryl® is indicated to be used as an adjunct to temporarily assist in securing periodontal
• D795013: PeriAcryl® is indicated to be used as an adjunct to temporarily assist in securing periodontal