Mach-2® S432S
GUDID 00810000524129
Starter Kit of Mach-2® Die Silicone
PARKELL, INC.
Silicone dental impression material| Primary Device ID | 00810000524129 |
| NIH Device Record Key | 1a50519c-f0fd-4219-a12b-0384949e2970 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Mach-2® |
| Version Model Number | S432S |
| Catalog Number | S432S |
| Company DUNS | 009900424 |
| Company Name | PARKELL, INC. |
| Device Count | 1 |
| 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 | false |
| 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
Operating and Storage Conditions
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810000524129 [Primary] |
FDA Product Code
| ELW | Material, Impression |
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 | 2019-09-19 |
| Device Publish Date | 2018-09-14 |
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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