MetaSeal® S163

GUDID 10810000529503

Scoops for MetaSeal® (Pkg. of 10 pcs.)

PARKELL, INC.

Endodontic filling/sealing material

• Primary Device ID: 10810000529503
• NIH Device Record Key: 34cde1ed-5dd6-4c90-9f05-fea5939d6d1b
• Commercial Distribution Discontinuation: 2020-03-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: MetaSeal®
• Version Model Number: S163
• Catalog Number: S163
• Company DUNS: 009900424
• Company Name: PARKELL, INC.
• Device Count: 10
• 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: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 6312491134
• Email: customerservice@parkell.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry location; Avoid excessive heat and moisture

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810000529506 [Unit of Use]
GS1	10810000529503 [Primary]

FDA Product Code

• KIF: Resin, Root Canal Filling

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-03-09
• Device Publish Date: 2019-08-16

On-Brand Devices [MetaSeal®]

• 00810000529490: MetaSeal® Powder 5gm
• 00810000529483: MetaSeal® Liquid 4.5ml
• 00810000529476: MetaSeal® Endodontic Sealer Kit
• 10810000529503: Scoops for MetaSeal® (Pkg. of 10 pcs.)