| Primary Device ID | 00083208235115 |
| NIH Device Record Key | 59af8a02-e432-4625-8f75-74195b4d981b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tatum Surgical/One Piece small ball head implant |
| Version Model Number | One Piece/3.5 x 11SB |
| Catalog Number | ITO3.5x11SB |
| Company DUNS | 078352849 |
| Company Name | Suncoast Dental, Inc |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(727)536-4880 |
| tatumimplants@verivon.net | |
| Phone | +1(727)536-4880 |
| tatumcompliance@gmail.com | |
| Phone | +1(727)536-4880 |
| tatumcompliance@gmail.com | |
| Phone | +1(727)536-4880 |
| tatumcompliance@gmail.com | |
| Phone | +1(727)536-4880 |
| tatumcompliance@gmail.com | |
| Phone | +1(727)536-4880 |
| tatumcompliance@gmail.com | |
| Phone | +1(727)536-4880 |
| tatumcompliance@gmail.com | |
| Phone | +1(727)536-4880 |
| tatumcompliance@gmail.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.5 Millimeter |
| Length | 11 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.5 Millimeter |
| Length | 11 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.5 Millimeter |
| Length | 11 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.5 Millimeter |
| Length | 11 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.5 Millimeter |
| Length | 11 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.5 Millimeter |
| Length | 11 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.5 Millimeter |
| Length | 11 Millimeter |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00083208235115 [Primary] |
| DZE | IMPLANT, ENDOSSEOUS, ROOT-FORM |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00083208235115]
Moist Heat or Steam Sterilization
[00083208235115]
Moist Heat or Steam Sterilization
[00083208235115]
Moist Heat or Steam Sterilization
[00083208235115]
Moist Heat or Steam Sterilization
[00083208235115]
Moist Heat or Steam Sterilization
[00083208235115]
Moist Heat or Steam Sterilization
[00083208235115]
Moist Heat or Steam Sterilization
[00083208235115]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-30 |
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