A+Wedge® GWAS01
GUDID 00810038095691
Wedge Sample Kit: 50 Count (25) X-Small Yellow, (25) Small Blue
GARRISON DENTAL SOLUTIONS, L.L.C.
Dental wedge, single-use Dental wedge, single-use Dental wedge, single-use Dental wedge, single-use Dental wedge, single-use Dental wedge, single-use Dental wedge, single-use Dental wedge, single-use Dental wedge, single-use Dental wedge, single-use Dental wedge, single-use Dental wedge, single-use Dental wedge, single-use Dental wedge, single-use Dental wedge, single-use Dental wedge, single-use Dental wedge, single-use Dental wedge, single-use| Primary Device ID | 00810038095691 |
| NIH Device Record Key | 397c49d3-9954-41cf-a7a8-485dcf334555 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | A+Wedge® |
| Version Model Number | GWAS01 |
| Catalog Number | GWAS01 |
| Company DUNS | 057647005 |
| Company Name | GARRISON DENTAL SOLUTIONS, L.L.C. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 888-437-0032 |
| gds@garrisondental.com | |
| Phone | 888-437-0032 |
| gds@garrisondental.com | |
| Phone | 888-437-0032 |
| gds@garrisondental.com | |
| Phone | 888-437-0032 |
| gds@garrisondental.com | |
| Phone | 888-437-0032 |
| gds@garrisondental.com | |
| Phone | 888-437-0032 |
| gds@garrisondental.com | |
| Phone | 888-437-0032 |
| gds@garrisondental.com | |
| Phone | 888-437-0032 |
| gds@garrisondental.com | |
| Phone | 888-437-0032 |
| gds@garrisondental.com | |
| Phone | 888-437-0032 |
| gds@garrisondental.com | |
| Phone | 888-437-0032 |
| gds@garrisondental.com | |
| Phone | 888-437-0032 |
| gds@garrisondental.com | |
| Phone | 888-437-0032 |
| gds@garrisondental.com | |
| Phone | 888-437-0032 |
| gds@garrisondental.com | |
| Phone | 888-437-0032 |
| gds@garrisondental.com | |
| Phone | 888-437-0032 |
| gds@garrisondental.com | |
| Phone | 888-437-0032 |
| gds@garrisondental.com | |
| Phone | 888-437-0032 |
| gds@garrisondental.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810038095691 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K140144
FDA Product Code
| EJB | Handle, Instrument, Dental |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810038095691]
Moist Heat or Steam Sterilization
[00810038095691]
Moist Heat or Steam Sterilization
[00810038095691]
Moist Heat or Steam Sterilization
[00810038095691]
Moist Heat or Steam Sterilization
[00810038095691]
Moist Heat or Steam Sterilization
[00810038095691]
Moist Heat or Steam Sterilization
[00810038095691]
Moist Heat or Steam Sterilization
[00810038095691]
Moist Heat or Steam Sterilization
[00810038095691]
Moist Heat or Steam Sterilization
[00810038095691]
Moist Heat or Steam Sterilization
[00810038095691]
Moist Heat or Steam Sterilization
[00810038095691]
Moist Heat or Steam Sterilization
[00810038095691]
Moist Heat or Steam Sterilization
[00810038095691]
Moist Heat or Steam Sterilization
[00810038095691]
Moist Heat or Steam Sterilization
[00810038095691]
Moist Heat or Steam Sterilization
[00810038095691]
Moist Heat or Steam Sterilization
[00810038095691]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-05-04 |
| Device Publish Date | 2020-04-24 |
On-Brand Devices [A+Wedge®]
| 00810038092997 | Wedge Refill, Large, Green |
| 00810038092980 | Wedge Refill, Medium, Orange |
| 00810038092973 | Wedge Refill, Small, Blue |
| 00810038092966 | Wedge Refill, X-Small, Yellow |
| 00810038095707 | Wedge Assortment Sample Kit: 100 Count (25 of Each Size) |
| 00810038095691 | Wedge Sample Kit: 50 Count (25) X-Small Yellow, (25) Small Blue |
| 00810038095684 | Complete Wedge Assorted Kit: 200 Count (50 of Each Size) |
Trademark Results [A+Wedge]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 A+WEDGE 86033473 4724547 Live/Registered |
Garrison Dental Solutions, LLC 2013-08-09 |
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