PDT, Inc. R983 Rev C

GUDID 00813677025135

Kit Includes: T015E-U FlipTop™ Cassette 'E' – Utility T018FM Silicone Finger Mat 10.75”x 8” R245 Mirror Handle (Cone-Socket) R437 Lucas 86 T040 Tweezers COLLEGE T050 #5 Front Surface Mirror, Cone-Socket, (15/16') T080 Tissue pliers ADSON T100 Retractor Caewood Minnesota 16 T102S Root elevator Seldin No. 301 straight Smooth Handle T104S Root elevator Seldin 34S Smooth Handle T118 Periosteal Elevator Molt 9 Hollow handle T235 Aspirating Anesthetic Syringe Medium T320 Elevator Fragment Ejector/Root Tip Pick, HEIDBRINK T704 Scalpel handle T714 TC Needle Holder CRILE WOOD T813 Scissors Goldman-Fox curved 12.5 T850 Miller-Colburn Bone File #1, Serrated

PDT, INC.

Dental surgical scissors

• Primary Device ID: 00813677025135
• NIH Device Record Key: 39279e1c-cbe9-40eb-a668-f23a4e506605
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PDT, Inc.
• Version Model Number: R983 Rev C Basic Extraction Kit
• Catalog Number: R983 Rev C
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00813677025135 [Primary]

FDA Product Code

• EJY: Pliers, Operative

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00813677025135]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00813677025135]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00813677025135]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00813677025135]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00813677025135]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00813677025135]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00813677025135]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00813677025135]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00813677025135]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00813677025135]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00813677025135]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00813677025135]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00813677025135]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00813677025135]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00813677025135]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00813677025135]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00813677025135]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-20
• Device Publish Date: 2024-08-12

On-Brand Devices [PDT, Inc.]

• 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