Mach-2® S431
GUDID 10810000524119
Base Former Trays for Mach-2® (Pkg. of 15 pcs.)
PARKELL, INC.
Dental impression tray, single-use| Primary Device ID | 10810000524119 |
| NIH Device Record Key | f6ed0097-f6d2-4c7d-87cf-efc289613d18 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Mach-2® |
| Version Model Number | S431 |
| Catalog Number | S431 |
| Company DUNS | 009900424 |
| Company Name | PARKELL, INC. |
| Device Count | 15 |
| 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 | true |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810000524112 [Unit of Use] |
| GS1 | 10810000524119 [Primary] |
FDA Product Code
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2021-06-30 |
| Device Publish Date | 2019-08-16 |
On-Brand Devices [Mach-2®]
| 00810000524129 | Starter Kit of Mach-2® Die Silicone |
| 10810000524119 | Base Former Trays for Mach-2® (Pkg. of 15 pcs.) |
| 10810000524133 | Mach-2® Die Silicone |
Trademark Results [Mach-2]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MACH-2 75245074 2134427 Live/Registered |
Parkell Inc. 1997-02-21 |
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