| Primary Device ID | 00850011211922 |
| NIH Device Record Key | 1da71072-eb6c-42e7-a7c3-3f9d8ba2c986 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GoldenDent |
| Version Model Number | GO WGD |
| Catalog Number | GO WGD |
| Company DUNS | 078273228 |
| Company Name | GoldenDent |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850011211922 [Primary] |
| EKF | INSTRUMENT, CONTOURING, MATRIX, OPERATIVE |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00850011211922]
Moist Heat or Steam Sterilization
[00850011211922]
Moist Heat or Steam Sterilization
[00850011211922]
Moist Heat or Steam Sterilization
[00850011211922]
Moist Heat or Steam Sterilization
[00850011211922]
Moist Heat or Steam Sterilization
[00850011211922]
Moist Heat or Steam Sterilization
[00850011211922]
Moist Heat or Steam Sterilization
[00850011211922]
Moist Heat or Steam Sterilization
[00850011211922]
Moist Heat or Steam Sterilization
[00850011211922]
Moist Heat or Steam Sterilization
[00850011211922]
Moist Heat or Steam Sterilization
[00850011211922]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-05 |
| Device Publish Date | 2021-02-25 |
| 00850028211892 | Coated Polyglycolic Acid (PGA) Braided Absorbable Suture Violet, 4-0, 19mm, 3/8 reverse cutting |
| 00850028211885 | Coated Polyglycolic Acid (PGA) Braided Absorbable Suture Violet, 3-0, 19mm, 3/8 reverse cutting |
| 00850028211212 | SeeMore Lip, Check and Tongue Retractor Small |
| 00850028211205 | SeeMore Lip, Check and Tongue Retractor Large |
| 00850028211878 | Golden-Taper Rotary Pack - Type SX (6 files) - Length 19mm |
| 00850028211861 | Golden-Taper Rotary Pack - Type S2 (6 files) - Length 31mm |
| 00850028211854 | Golden-Taper Rotary Pack - Type S2 (6 files) - Length 25mm |
| 00850028211847 | Golden-Taper Rotary Pack - Type S2 (6 files) - Length 21mm |
| 00850028211830 | Golden-Taper Rotary Pack - Type S1 (6 files) - Length 31mm |
| 00850028211823 | Golden-Taper Rotary Pack - Type S1 (6 files) - Length 25mm |
| 00850028211816 | Golden-Taper Rotary Pack - Type S1 (6 files) - Length 21mm |
| 00850028211809 | Golden-Taper Rotary Pack - Type F5 (6 files) - length 31mm |
| 00850028211793 | Golden-Taper Rotary Pack - Type F5 (6 files) - length 25mm |
| 00850028211786 | Golden-Taper Rotary Pack - Type F5 (6 files) - length 21mm |
| 00850028211779 | Golden-Taper Rotary - Type F4 (6 files) - Length 31mm |
| 00850028211762 | Golden-Taper Rotary - Type F4 (6 files) - Length 25mm |
| 00850028211755 | Golden-Taper Rotary - Type F4 (6 files) - Length 21mm |
| 00850028211748 | Golden-Taper Rotary Pack - Type F3 (6 files) - Length 31mm |
| 00850028211731 | Golden-Taper Rotary Pack - Type F3 (6 files) - Length 25mm |
| 00850028211724 | Golden-Taper Rotary Pack - Type F3 (6 files) - Length 21mm |
| 00850028211717 | Golden-Taper Rotary Pack - Type F2 (6 files) - Length 31mm |
| 00850028211700 | Golden-Taper Rotary Pack - Type F2 (6 files) - Length 25mm |
| 00850028211694 | Golden-Taper Rotary Pack - Type F2 (6 files) - Length 21mm |
| 00850028211687 | Golden-Taper Rotary Pack - Type F1 (6 files) - Length 31mm |
| 00850028211670 | Golden-Taper Rotary Pack - Type F1 (6 files) - Length 25mm |
| 00850028211519 | Golden-Taper Rotary Pack - Type F1 (6 files) - Length 21mm |
| 00850011211977 | Golden-Taper Rotary Assorted Pack- SX, S1, S2, F1, F2 & F3 (6 files) - Length 31mm |
| 00850011211960 | Golden-Taper Rotary Assorted Pack- SX, S1, S2, F1, F2 & F3 (6 files) - Length 25mm |
| 00850011211953 | Golden-Taper Rotary Assorted Pack- SX, S1, S2, F1, F2 & F3 (6 files) - Length 21mm |
| 00850011211922 | Weighted Graft Material Dish |
| 00850011211915 | Combination Graft Spoon Packer |
| 00850011211908 | Scalpel Handel #3 |
| 00850011211892 | Periosteal Elevator Molt #9 |
| 00850011211885 | Orban Knife |
| 00850011211878 | Non Serrated Tissue Membrane Force |
| 00850011211861 | Needle Holder |
| 00850011211854 | Double Ended Socket Currette |
| 00850011211847 | Curved Graft Scissor |
| 00850011211830 | Grafting Cassette |
| 00850011211823 | Bone File #10 |
| 00850011211816 | Flex Series Micro Serrated Intro Kit (GO SS6, GO SS7) |
| 00850011211809 | Separators Root Tip Kit (GO-SS4, GO-SS5) |
| 00850011211793 | Twist Separator Intro Kit (GO-SS8, GO-SS9, GO-SS10, GO-SS11) |
| 00850011211786 | Separators Intro Kit (GO-SS1, GO-SS2, GO-SS3, GO- SS4, GO-SS5, GO SS6, GO SS7) |
| 00850011211779 | Separators Essential Kit (GO-SS1, GO-SS2, GO-SS3) |
| 00850011211762 | Separator #11-Twist Separator Angled Left |
| 00850011211755 | Separator #10-Twist Separator Angled Right |
| 00850011211748 | Separator #9-Twist Separator Straight Left |
| 00850011211731 | Separator #8 -Twist Separator Straight Right |
| 00850011211724 | Flex Series -Micro Serrated Separator #2 Posterior |