| Primary Device ID | 00810008463178 |
| NIH Device Record Key | be7f4e13-82d6-4e41-8cda-d894c740632d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | THE PAMELA RAY™ |
| Version Model Number | PH3813 |
| Company DUNS | 050003777 |
| Company Name | Little Implant Co. |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810008463178 [Primary] |
| DZE | Implant, Endosseous, Root-Form |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-02-08 |
| Device Publish Date | 2019-01-08 |
| 00810008463185 | THE PAMELA RAY™ Internal Hex Implant 3.85 dia. x L15mm |
| 00810008463178 | THE PAMELA RAY™ Internal Hex Implant 3.85 dia. x L13mm |
| 00810008463161 | THE PAMELA RAY™ Internal Hex Implant 3.85 dia. x 11.5mm |
| 00810008463154 | THE PAMELA RAY™ Internal Hex Implant 3.85 dia. x L10mm |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() THE PAMELA RAY 88174486 not registered Live/Pending |
OsteoReady, LLC 2018-10-30 |