Primary Device ID | 00841549116124 |
NIH Device Record Key | 5e9ff75e-7775-446b-ac42-43bd72b9dd9c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ERA® |
Version Model Number | 811025 |
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 |
Phone | 5082265660 |
laura.greige@sterngold.com | |
Phone | 5082265660 |
laura.greige@sterngold.com | |
Phone | 5082265660 |
laura.greige@sterngold.com | |
Phone | 5082265660 |
laura.greige@sterngold.com | |
Phone | 5082265660 |
laura.greige@sterngold.com | |
Phone | 5082265660 |
laura.greige@sterngold.com | |
Phone | 5082265660 |
laura.greige@sterngold.com | |
Phone | 5082265660 |
laura.greige@sterngold.com | |
Phone | 5082265660 |
laura.greige@sterngold.com | |
Phone | 5082265660 |
laura.greige@sterngold.com | |
Phone | 5082265660 |
laura.greige@sterngold.com | |
Phone | 5082265660 |
laura.greige@sterngold.com | |
Phone | 5082265660 |
laura.greige@sterngold.com | |
Phone | 5082265660 |
laura.greige@sterngold.com | |
Phone | 5082265660 |
laura.greige@sterngold.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00841549116124 [Primary] |
NDP | Accessories, Implant, Dental, Endosseous |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00841549116124]
Moist Heat or Steam Sterilization
[00841549116124]
Moist Heat or Steam Sterilization
[00841549116124]
Moist Heat or Steam Sterilization
[00841549116124]
Moist Heat or Steam Sterilization
[00841549116124]
Moist Heat or Steam Sterilization
[00841549116124]
Moist Heat or Steam Sterilization
[00841549116124]
Moist Heat or Steam Sterilization
[00841549116124]
Moist Heat or Steam Sterilization
[00841549116124]
Moist Heat or Steam Sterilization
[00841549116124]
Moist Heat or Steam Sterilization
[00841549116124]
Moist Heat or Steam Sterilization
[00841549116124]
Moist Heat or Steam Sterilization
[00841549116124]
Moist Heat or Steam Sterilization
[00841549116124]
Moist Heat or Steam Sterilization
[00841549116124]
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 |