| Primary Device ID | 08136770200608 |
| NIH Device Record Key | a867f75e-5637-4df7-b1dc-a6e85ade6b8f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PDT, Inc. |
| Version Model Number | Gracey 11-12 ER Mini |
| Catalog Number | R006 |
| Company DUNS | 125850144 |
| Company Name | PDT, 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 | 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08136770200608 [Primary] |
| EMS | Curette, Periodontic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08136770200608]
Moist Heat or Steam Sterilization
[08136770200608]
Moist Heat or Steam Sterilization
[08136770200608]
Moist Heat or Steam Sterilization
[08136770200608]
Moist Heat or Steam Sterilization
[08136770200608]
Moist Heat or Steam Sterilization
[08136770200608]
Moist Heat or Steam Sterilization
[08136770200608]
Moist Heat or Steam Sterilization
[08136770200608]
Moist Heat or Steam Sterilization
[08136770200608]
Moist Heat or Steam Sterilization
[08136770200608]
Moist Heat or Steam Sterilization
[08136770200608]
Moist Heat or Steam Sterilization
[08136770200608]
Moist Heat or Steam Sterilization
[08136770200608]
Moist Heat or Steam Sterilization
[08136770200608]
Moist Heat or Steam Sterilization
[08136770200608]
Moist Heat or Steam Sterilization
[08136770200608]
Moist Heat or Steam Sterilization
[08136770200608]
Moist Heat or Steam Sterilization
[08136770200608]
Moist Heat or Steam Sterilization
[08136770200608]
Moist Heat or Steam Sterilization
[08136770200608]
Moist Heat or Steam Sterilization
[08136770200608]
Moist Heat or Steam Sterilization
[08136770200608]
Moist Heat or Steam Sterilization
[08136770200608]
Moist Heat or Steam Sterilization
[08136770200608]
Moist Heat or Steam Sterilization
[08136770200608]
Moist Heat or Steam Sterilization
[08136770200608]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-09 |
| Device Publish Date | 2020-09-01 |
| 08136770201001 | Gracey 1-2 ER Mini |
| 08136770200905 | Gracey 17-18 ER Mini |
| 08136770200813 | Gracey 15-16 ER Mini Rigid |
| 08136770200806 | Gracey 15-16 ER Mini |
| 08136770200714 | Gracey 13-14 ER Mini Rigid |
| 08136770200707 | Gracey 13-14 ER Mini |
| 08136770200615 | Gracey 11-12 ER Mini Rigid |
| 08136770200608 | Gracey 11-12 ER Mini |
| 08136770200516 | Gracey 9-10 ER Mini Rigid |
| 08136770200509 | Gracey 9-10 ER Mini |
| 08136770200417 | Gracey 7-8 ER Mini Rigid |
| 08136770200400 | Gracey 7-8 ER Mini |
| 08136770200301 | Gracey 5-6 ER Mini |
| 08136770200110 | Gracey 00 Rigid |
| 08136770200103 | Gracey 00 |
| 08136770212502 | J34-35 |
| 00813677020024 | Gracey 00 |
| 00813677020826 | Montana 4-5 Scaler |
| 00813677021632 | R311 DG 16 Explorer |
| 00813677022479 | R363 113 Straight Cord Packer |
| 00813677022349 | R696 Gracey 13-14 Titanium Extended Reach Micro M |
| 00813677022332 | R694 Gracey 1-2 Titanium Extended Reach Micro Min |
| 00813677022325 | R695 Gracey 11-12 Titanium Extended Reach Micro M |
| 00813677022318 | R693 Wingrove™ N128 Blunt-Langer 5 Mini Titanium |
| 00813677022301 | R680 Wingrove™ L3-4 Titanium Implant |
| 00813677022295 | R661 Wingrove™ B5-6 Titanium Implant |
| 00813677022288 | R633 Pineyro ArchTM Ti 4 |
| 00813677022271 | R632 Pineyro ArchTM Ti 3 |
| 00813677022264 | R631 Pineyro ArchTM Ti 2 |
| 00813677022257 | R630 Pineyro ArchTM Ti 1 |
| 00813677022240 | R563 Composite DRV™ 7-8 |
| 00813677022233 | R562 Composite DRV™ 5-6 |
| 00813677022226 | R561 Composite DRV™ 3-4 |
| 00813677022219 | R560 Composite DRV™ 1-2 |
| 00813677022202 | R542 8A Composite System |
| 00813677022196 | R538 IPC-L Composite System |
| 00813677022189 | R534 IPC-T Composite System |
| 00813677022172 | R530 CSS-6 Composite System |
| 00813677022165 | R526 CSS-5 Composite System |
| 00813677022158 | R522 CSS-4 Composite System |
| 00813677022141 | R518 CSS-3 Composite System |
| 00813677022134 | R514 CSS-2 Composite System |
| 00813677022103 | R445 Modified Orban Knife |
| 00813677022097 | R444 End Cutting Intrasulcular Knife |
| 00813677022080 | R443 3 mm Periosteal Elevator |
| 00813677022073 | R442 2 mm Periosteal Elevator |
| 00813677022066 | R437 Lucas 86 |
| 00813677022059 | R436 Slade Blade 5, Posterior Wide Without Serrat |
| 00813677022042 | R435 Slade Blade 4, Posterior Wide |
| 00813677022035 | R434 Slade Blade 3, Posterior Narrow |