O-Ring Purple Xtra Strong

GUDID 00841549119149

for 1.8mm Ball (10 Pack)

STERNGOLD DENTAL LLC

Resilient dental precision attachment

• Primary Device ID: 00841549119149
• NIH Device Record Key: 208c3dd1-3cb8-4234-91ef-bb598eefea8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: O-Ring Purple Xtra Strong
• Version Model Number: 909016
• Company DUNS: 124763728
• Company Name: STERNGOLD DENTAL LLC
• 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: 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: 508-226-5660
• Email: laura.greige@sterngold.com
• Phone: 508-226-5660
• Email: laura.greige@sterngold.com
• Phone: 508-226-5660
• Email: laura.greige@sterngold.com
• Phone: 508-226-5660
• Email: laura.greige@sterngold.com
• Phone: 508-226-5660
• Email: laura.greige@sterngold.com
• Phone: 508-226-5660
• Email: laura.greige@sterngold.com
• Phone: 508-226-5660
• Email: laura.greige@sterngold.com
• Phone: 508-226-5660
• Email: laura.greige@sterngold.com
• Phone: 508-226-5660
• Email: laura.greige@sterngold.com
• Phone: 508-226-5660
• Email: laura.greige@sterngold.com
• Phone: 508-226-5660
• Email: laura.greige@sterngold.com
• Phone: 508-226-5660
• Email: laura.greige@sterngold.com
• Phone: 508-226-5660
• Email: laura.greige@sterngold.com
• Phone: 508-226-5660
• Email: laura.greige@sterngold.com
• Phone: 508-226-5660
• Email: laura.greige@sterngold.com
• Phone: 508-226-5660
• Email: laura.greige@sterngold.com
• Phone: 508-226-5660
• Email: laura.greige@sterngold.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841549119149 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153173

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[00841549119149]

Moist Heat or Steam Sterilization

[00841549119149]

Moist Heat or Steam Sterilization

[00841549119149]

Moist Heat or Steam Sterilization

[00841549119149]

Moist Heat or Steam Sterilization

[00841549119149]

Moist Heat or Steam Sterilization

[00841549119149]

Moist Heat or Steam Sterilization

[00841549119149]

Moist Heat or Steam Sterilization

[00841549119149]

Moist Heat or Steam Sterilization

[00841549119149]

Moist Heat or Steam Sterilization

[00841549119149]

Moist Heat or Steam Sterilization

[00841549119149]

Moist Heat or Steam Sterilization

[00841549119149]

Moist Heat or Steam Sterilization

[00841549119149]

Moist Heat or Steam Sterilization

[00841549119149]

Moist Heat or Steam Sterilization

[00841549119149]

Moist Heat or Steam Sterilization

[00841549119149]

Moist Heat or Steam Sterilization

[00841549119149]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-13
• Device Publish Date: 2023-10-05

On-Brand Devices [O-Ring Purple Xtra Strong ]

• 00841549119156: for 2.2mm Ball (10 Pack)
• 00841549119149: for 1.8mm Ball (10 Pack)