| Primary Device ID | 00841549116131 |
| NIH Device Record Key | 3a682e0b-2c14-42a1-a22a-eb8d63b0bfc6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ERA® |
| Version Model Number | 811026 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841549116131 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00841549116131]
Moist Heat or Steam Sterilization
[00841549116131]
Moist Heat or Steam Sterilization
[00841549116131]
Moist Heat or Steam Sterilization
[00841549116131]
Moist Heat or Steam Sterilization
[00841549116131]
Moist Heat or Steam Sterilization
[00841549116131]
Moist Heat or Steam Sterilization
[00841549116131]
Moist Heat or Steam Sterilization
[00841549116131]
Moist Heat or Steam Sterilization
[00841549116131]
Moist Heat or Steam Sterilization
[00841549116131]
Moist Heat or Steam Sterilization
[00841549116131]
Moist Heat or Steam Sterilization
[00841549116131]
Moist Heat or Steam Sterilization
[00841549116131]
Moist Heat or Steam Sterilization
[00841549116131]
Moist Heat or Steam Sterilization
[00841549116131]
Moist Heat or Steam Sterilization
[00841549116131]
Moist Heat or Steam Sterilization
[00841549116131]
Moist Heat or Steam Sterilization
[00841549116131]
Moist Heat or Steam Sterilization
[00841549116131]
Moist Heat or Steam Sterilization
[00841549116131]
Moist Heat or Steam Sterilization
[00841549116131]
Moist Heat or Steam Sterilization
[00841549116131]
Moist Heat or Steam Sterilization
[00841549116131]
Moist Heat or Steam Sterilization
[00841549116131]
Moist Heat or Steam Sterilization
[00841549116131]
Moist Heat or Steam Sterilization
[00841549116131]
Moist Heat or Steam Sterilization
[00841549116131]
Moist Heat or Steam Sterilization
[00841549116131]
Moist Heat or Steam Sterilization
[00841549116131]
Moist Heat or Steam Sterilization
[00841549116131]
Moist Heat or Steam Sterilization
[00841549116131]
Moist Heat or Steam Sterilization
[00841549116131]
Moist Heat or Steam Sterilization
[00841549116131]
Moist Heat or Steam Sterilization
[00841549116131]
Moist Heat or Steam Sterilization
[00841549116131]
Moist Heat or Steam Sterilization
[00841549116131]
Moist Heat or Steam Sterilization
[00841549116131]
Moist Heat or Steam Sterilization
[00841549116131]
Moist Heat or Steam Sterilization
[00841549116131]
Moist Heat or Steam Sterilization
[00841549116131]
Moist Heat or Steam Sterilization
[00841549116131]
Moist Heat or Steam Sterilization
[00841549116131]
Moist Heat or Steam Sterilization
[00841549116131]
Moist Heat or Steam Sterilization
[00841549116131]
Moist Heat or Steam Sterilization
[00841549116131]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-27 |
| Device Publish Date | 2023-07-19 |
| 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 |