Knit-Pak+

GUDID 00348783001846

Premier® Knit-Pak™+ Aluminum Chloride Impregnated Retraction Cord, Orange- Size 2, Length – 100inch(254cm)

PREMIER DENTAL PRODUCTS COMPANY

Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated

• Primary Device ID: 00348783001846
• NIH Device Record Key: 8bd6bc44-3a76-464f-a996-5f9907c8ce35
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Knit-Pak+
• Version Model Number: 9007565
• Company DUNS: 014789663
• Company Name: PREMIER DENTAL PRODUCTS COMPANY
• 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: true
• 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
GS1	00348783001846 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132526

FDA Product Code

• MVL: Cord, Retraction

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: 2024-04-03
• Device Publish Date: 2024-01-09

On-Brand Devices [Knit-Pak+]

• 00348783001853: Premier® Knit-Pak™+ Aluminum Chloride Impregnated Retraction Cord Sample Pack, Brown - Size 0
• 00348783001846: Premier® Knit-Pak™+ Aluminum Chloride Impregnated Retraction Cord, Orange- Size 2, Length –
• 00348783001839: Premier® Knit-Pak™+ Aluminum Chloride Impregnated Retraction Cord, Blue - Size 1, Length –
• 00348783001822: Premier® Knit-Pak™+ Aluminum Chloride Impregnated Retraction Cord, Purple - Size 0, Length �
• 00348783001815: Premier® Knit-Pak™+ Aluminum Chloride Impregnated Retraction Cord, Brown - Size 00, Length �
• 00348783001808: Premier® Knit-Pak™+ Aluminum Chloride Impregnated Retraction Cord, Green - Size 000, Length �
• 00348783001792: Premier® Knit-Pak™+ Aluminum Chloride Impregnated Retraction Cord, Dark Green - Size 000.0, L