O-Ring Purple Xtra Strong

GUDID 00841549119156

for 2.2mm Ball (10 Pack)

STERNGOLD DENTAL LLC

Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment Resilient dental precision attachment

• Primary Device ID: 00841549119156
• NIH Device Record Key: c6a986f7-fa47-487a-9082-32bc8048d772
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: O-Ring Purple Xtra Strong
• Version Model Number: 909018
• 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	00841549119156 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133791

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[00841549119156]

Moist Heat or Steam Sterilization

[00841549119156]

Moist Heat or Steam Sterilization

[00841549119156]

Moist Heat or Steam Sterilization

[00841549119156]

Moist Heat or Steam Sterilization

[00841549119156]

Moist Heat or Steam Sterilization

[00841549119156]

Moist Heat or Steam Sterilization

[00841549119156]

Moist Heat or Steam Sterilization

[00841549119156]

Moist Heat or Steam Sterilization

[00841549119156]

Moist Heat or Steam Sterilization

[00841549119156]

Moist Heat or Steam Sterilization

[00841549119156]

Moist Heat or Steam Sterilization

[00841549119156]

Moist Heat or Steam Sterilization

[00841549119156]

Moist Heat or Steam Sterilization

[00841549119156]

Moist Heat or Steam Sterilization

[00841549119156]

Moist Heat or Steam Sterilization

[00841549119156]

Moist Heat or Steam Sterilization

[00841549119156]

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)