| Primary Device ID | 00083208130441 |
| NIH Device Record Key | 5c512938-1f2f-4276-9cea-ed81f60b93d6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Zoll, Inside-Action Winged Elevator |
| Version Model Number | Inside-Action Winged Elevator EX W5IB 501 |
| Catalog Number | Elevator - Winged Inside EXW5IB 501 |
| Company DUNS | 078352849 |
| Company Name | Suncoast Dental, Inc |
| Device Count | 1 |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00083208130441 [Primary] |
| EMJ | Elevator, Surgical, Dental |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00083208130441]
Moist Heat or Steam Sterilization
[00083208130441]
Moist Heat or Steam Sterilization
[00083208130441]
Moist Heat or Steam Sterilization
[00083208130441]
Moist Heat or Steam Sterilization
[00083208130441]
Moist Heat or Steam Sterilization
[00083208130441]
Moist Heat or Steam Sterilization
[00083208130441]
Moist Heat or Steam Sterilization
[00083208130441]
Moist Heat or Steam Sterilization
[00083208130441]
Moist Heat or Steam Sterilization
[00083208130441]
Moist Heat or Steam Sterilization
[00083208130441]
Moist Heat or Steam Sterilization
[00083208130441]
Moist Heat or Steam Sterilization
[00083208130441]
Moist Heat or Steam Sterilization
[00083208130441]
Moist Heat or Steam Sterilization
[00083208130441]
Moist Heat or Steam Sterilization
[00083208130441]
Moist Heat or Steam Sterilization
[00083208130441]
Moist Heat or Steam Sterilization
[00083208130441]
Moist Heat or Steam Sterilization
[00083208130441]
Moist Heat or Steam Sterilization
[00083208130441]
Moist Heat or Steam Sterilization
[00083208130441]
Moist Heat or Steam Sterilization
[00083208130441]
Moist Heat or Steam Sterilization
[00083208130441]
Moist Heat or Steam Sterilization
[00083208130441]
Moist Heat or Steam Sterilization
[00083208130441]
Moist Heat or Steam Sterilization
[00083208130441]
Moist Heat or Steam Sterilization
[00083208130441]
Moist Heat or Steam Sterilization
[00083208130441]
Moist Heat or Steam Sterilization
[00083208130441]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-04-15 |
| Device Publish Date | 2022-04-07 |
| 00083208135002 - DDP Dental Mirror | 2024-02-07 Dental Mirror, reusable |
| 00083208136702 - DDP Extraction Forceps | 2024-02-07 Tooth Extraction Forceps 67A |
| 00083208452215 - Tatum Surgical IP Press Fit Abutment | 2023-01-13 0° (Degree) Shouldered Abutment for 4.5mm Diameter "P" Implants 2.0mm Cuff Height |
| 00083208453212 - Tatum Surgical IP Press Fit Abutment | 2023-01-13 0° (Degree) Shouldered Abutment for 4.5mm Diameter "P" Implants 3.0mm Cuff Height |
| 00083208454219 - Tatum Surgical IP Press Fit Abutment | 2023-01-13 0° (Degree) Shouldered Abutment for 4.5mm Diameter "P" Implants 4.0mm Cuff Height |
| 00083208455216 - Tatum Surgical IP Press Fit Abutment | 2023-01-13 0° (Degree) Shouldered Abutment for 4.5mm Diameter "P" Implants 5.0mm Cuff Height |
| 00083208456213 - Tatum Surgical IP Press Fit Abutment | 2023-01-13 0° (Degree) Shouldered Abutment for 4.5mm Diameter "P" Implants 6.0mm Cuff Height |
| 00083208502217 - Tatum Surgical IP Press Fit Abutment | 2023-01-13 0° (Degree) Shouldered Abutment for 5.0mm Diameter "P" Implants 2.0mm Cuff Height |