| Primary Device ID | 00850011211304 |
| NIH Device Record Key | d1f7c043-9da6-49b6-8ff0-95fe32d50d2f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Golden Force Series |
| Version Model Number | GF IKF |
| Catalog Number | GF IKF |
| 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 | true |
| Device Combination Product | true |
| 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 | 00850011211304 [Primary] |
| EMG | FORCEPS, TOOTH EXTRACTOR, SURGICAL |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00850011211304]
Moist Heat or Steam Sterilization
[00850011211304]
Moist Heat or Steam Sterilization
[00850011211304]
Moist Heat or Steam Sterilization
[00850011211304]
Moist Heat or Steam Sterilization
[00850011211304]
Moist Heat or Steam Sterilization
[00850011211304]
Moist Heat or Steam Sterilization
[00850011211304]
Moist Heat or Steam Sterilization
[00850011211304]
Moist Heat or Steam Sterilization
[00850011211304]
Moist Heat or Steam Sterilization
[00850011211304]
Moist Heat or Steam Sterilization
[00850011211304]
Moist Heat or Steam Sterilization
[00850011211304]
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 |
| 00850011211939 - GoldenDent | 2021-03-08 Advanced Grafting Kit (11 Instruments and Cassette) |
| 00850011211946 - GoldenDent | 2021-03-08 Grafting Instrument Kit (11 Instruments) |
| 00850011211014 - GoldenDent | 2021-03-05 Broken File Extraction Intro Kit: Included 45, 75, 90 & 100 degree retrieval probes |
| 00850011211021 - GoldenDent | 2021-03-05 Endo File Forcep #1 90 Degree in line access |
| 00850011211038 - GoldenDent | 2021-03-05 Endo File Forcep #2 75 Degree in line access |
| 00850011211045 - GoldenDent | 2021-03-05 Featherlike Suture Scissors |
| 00850011211052 - GoldenDent | 2021-03-05 Healing Abutment Forcep #1 90 Degree |
| 00850011211069 - GoldenDent | 2021-03-05 Healing Abutment Forcep #1 75 Degree |