GS80 4423202
GUDID DO3644232022
SDI LIMITED
Dental amalgam alloy| Primary Device ID | DO3644232022 |
| NIH Device Record Key | 5ea29026-40b9-40a6-81c9-c261a4b31d24 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GS80 |
| Version Model Number | GS80 3SP FAST 500 |
| Catalog Number | 4423202 |
| Company DUNS | 753221852 |
| Company Name | SDI LIMITED |
| Device Count | 500 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| 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 | +18002285166 |
| info@sdi.com.au | |
| Phone | +18002285166 |
| info@sdi.com.au | |
| Phone | +18002285166 |
| info@sdi.com.au | |
| Phone | +18002285166 |
| info@sdi.com.au | |
| Phone | +18002285166 |
| info@sdi.com.au | |
| Phone | +18002285166 |
| info@sdi.com.au | |
| Phone | +18002285166 |
| info@sdi.com.au | |
| Phone | +18002285166 |
| info@sdi.com.au | |
| Phone | +18002285166 |
| info@sdi.com.au | |
| Phone | +18002285166 |
| info@sdi.com.au | |
| Phone | +18002285166 |
| info@sdi.com.au | |
| Phone | +18002285166 |
| info@sdi.com.au | |
| Phone | +18002285166 |
| info@sdi.com.au | |
| Phone | +18002285166 |
| info@sdi.com.au | |
| Phone | +18002285166 |
| info@sdi.com.au | |
| Phone | +18002285166 |
| info@sdi.com.au | |
| Phone | +18002285166 |
| info@sdi.com.au |
Operating and Storage Conditions
| Handling Environment Atmospheric Pressure | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 0 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | DO3644232020 [Unit of Use] |
| HIBCC | DO3644232022 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K801639
FDA Product Code
| EJJ | Alloy, amalgam |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-26 |
On-Brand Devices [GS80]
| DO3644603032 | GS80 ALLOY REG 5OZ |
| DO3644503032 | GS80 TABS REG 5OZ |
| DO3644250002 | GS80 5SP REG 500 |
| DO3644234042 | GS80 3SP SLOW 500 |
| DO3644233032 | GS80 3SP REG 500 |
| DO3644232022 | GS80 3SP FAST 500 |
| DO3644224042 | GS80 2SP SLOW 500 |
| DO3644223032 | GS80 2SP REG 500 |
| DO3644222022 | GS80 2SP FAST 500 |
| DO3644214042 | GS80 1SP SLOW 500 |
| DO3644213032 | GS80 1SP REG 500 |
| DO3644212022 | GS80 1SP FAST 500 |
| DO3644050002 | GS80 5SP REG 50 |
| DO3644034042 | GS80 3SP SLOW 50 |
| DO3644033032 | GS80 3SP REG 50 |
| DO3644032022 | GS80 3SP FAST 50 |
| DO3644024042 | GS80 2SP SLOW 50 |
| DO3644023032 | GS80 2SP REG 50 |
| DO3644022022 | GS80 2SP FAST 50 |
| DO3644014042 | GS80 1SP SLOW 50 |
| DO3644013032 | GS80 1SP REG 50 |
| DO3644012022 | GS80 1SP FAST 50 |
| 09336472003784 | GS80 5SP REG 500 |
| 09336472003746 | GS80 3SP SLOW 500 |
| 09336472003708 | GS80 3SP REG 500 |
| 09336472003661 | GS80 3SP FAST 500 |
| 09336472003623 | GS80 2SP SLOW 500 |
| 09336472003586 | GS80 2SP REG 500 |
| 09336472003548 | GS80 2SP FAST 500 |
| 09336472003456 | GS80 1SP REG 500 |
| 09336472003418 | GS80 1SP FAST 500 |
| 09336472002954 | GS80 5SP REG 50 |
| 09336472002916 | GS80 3SP SLOW 50 |
| 09336472002848 | GS80 3SP REG 50 |
| 09336472002800 | GS80 3SP FAST 50 |
| 09336472002763 | GS80 2SP SLOW 50 |
| 09336472002688 | GS80 2SP REG 50 |
| 09336472002626 | GS80 2SP FAST 50 |
| 09336472002527 | GS80 1SP REG 50 |
| 09336472002480 | GS80 1SP FAST 50 |
Trademark Results [GS80]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GS80 78554335 3604317 Dead/Cancelled |
Greer Industries, Inc. 2005-01-26 |
 GS80 74649255 not registered Dead/Abandoned |
PRIMWELL INVESTMENT PTE. LTD. 1995-03-20 |
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