ERA®

GUDID 00841549116100

Micro Core Cutter Bur

STERNGOLD DENTAL LLC

Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable

• Primary Device ID: 00841549116100
• NIH Device Record Key: 6facf189-235c-418f-8f94-a4f8c788ed39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ERA®
• Version Model Number: 811023
• Company DUNS: 124763728
• Company Name: STERNGOLD DENTAL LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841549116100 [Primary]

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

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

[00841549116100]

Moist Heat or Steam Sterilization

[00841549116100]

Moist Heat or Steam Sterilization

[00841549116100]

Moist Heat or Steam Sterilization

[00841549116100]

Moist Heat or Steam Sterilization

[00841549116100]

Moist Heat or Steam Sterilization

[00841549116100]

Moist Heat or Steam Sterilization

[00841549116100]

Moist Heat or Steam Sterilization

[00841549116100]

Moist Heat or Steam Sterilization

[00841549116100]

Moist Heat or Steam Sterilization

[00841549116100]

Moist Heat or Steam Sterilization

[00841549116100]

Moist Heat or Steam Sterilization

[00841549116100]

Moist Heat or Steam Sterilization

[00841549116100]

Moist Heat or Steam Sterilization

[00841549116100]

Moist Heat or Steam Sterilization

[00841549116100]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-27
• Device Publish Date: 2023-07-19

On-Brand Devices [ERA® ]

• 00841549117688: Long Shank, Hand Driver, .035"
• 00841549116391: Standard Long Torque Adaptor
• 00841549116384: Standard Short Torque Adaptor
• 00841549116377: Std. Imp. Abutment Tool Kit
• 00841549116360: Micro Imp. Abutment Tool Kit
• 00841549116353: Micro Alignment Handles (2)
• 00841549116346: Standard Alignment Handles (2)
• 00841549116339: Standard Ovd. Processing Jig
• 00841549116322: RV Partial Processing Jig
• 00841549116315: RV/Std.Ovd Dentist Tool Kit
• 00841549116261: RV/Std.Ovd Seating Tool
• 00841549116230: RV/Std.Ovd Core Cutter Bur
• 00841549116223: RV/Std.Ovd Paralleling Mandrel
• 00841549116216: RV/Std.Ovd Lab Tool Kit
• 00841549116209: ANGLE GAUGE KIT
• 00841549116193: Angle Gauge 17° Etched
• 00841549116186: Angle Gauge 11° Etched
• 00841549116179: Angle Gauge 5° Etched
• 00841549116162: Angle Gauge 0° Etched
• 00841549116155: Micro Ovd. Processing Jig
• 00841549116131: Micro Dentist Tool Kit
• 00841549116124: Micro Lab Tool Kit
• 00841549116117: Micro Paralleling Mandrel
• 00841549116100: Micro Core Cutter Bur
• 00841549116094: Micro Seating Tool
• 00841549116087: Micro Partial Processing Jig