PDT, Inc. R311

GUDID 00813677021632

PDT, INC.

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Primary Device ID00813677021632
NIH Device Record Keyc67cfc99-83ac-4a0c-b37b-c6e5a7e7575e
Commercial Distribution StatusIn Commercial Distribution
Brand NamePDT, Inc.
Version Model NumberR311 DG 16 Explorer
Catalog NumberR311
Company DUNS125850144
Company NamePDT, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100813677021632 [Primary]

FDA Product Code

EKBExplorer, Operative

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00813677021632]

Moist Heat or Steam Sterilization


[00813677021632]

Moist Heat or Steam Sterilization


[00813677021632]

Moist Heat or Steam Sterilization


[00813677021632]

Moist Heat or Steam Sterilization


[00813677021632]

Moist Heat or Steam Sterilization


[00813677021632]

Moist Heat or Steam Sterilization


[00813677021632]

Moist Heat or Steam Sterilization


[00813677021632]

Moist Heat or Steam Sterilization


[00813677021632]

Moist Heat or Steam Sterilization


[00813677021632]

Moist Heat or Steam Sterilization


[00813677021632]

Moist Heat or Steam Sterilization


[00813677021632]

Moist Heat or Steam Sterilization


[00813677021632]

Moist Heat or Steam Sterilization


[00813677021632]

Moist Heat or Steam Sterilization


[00813677021632]

Moist Heat or Steam Sterilization


[00813677021632]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-08
Device Publish Date2021-03-31

On-Brand Devices [PDT, Inc.]

08136770201001Gracey 1-2 ER Mini
08136770200905Gracey 17-18 ER Mini
08136770200813Gracey 15-16 ER Mini Rigid
08136770200806Gracey 15-16 ER Mini
08136770200714Gracey 13-14 ER Mini Rigid
08136770200707Gracey 13-14 ER Mini
08136770200615Gracey 11-12 ER Mini Rigid
08136770200608Gracey 11-12 ER Mini
08136770200516Gracey 9-10 ER Mini Rigid
08136770200509Gracey 9-10 ER Mini
08136770200417Gracey 7-8 ER Mini Rigid
08136770200400Gracey 7-8 ER Mini
08136770200301Gracey 5-6 ER Mini
08136770200110Gracey 00 Rigid
08136770200103Gracey 00
08136770212502J34-35
00813677020024Gracey 00
00813677020826Montana 4-5 Scaler
00813677021632R311 DG 16 Explorer

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