FDA.reportPublic FDA data

PDT, Inc.

Primary DI
00813677023223
Brand
PDT, Inc.
Company
PDT, INC.
Model
T731 Micro-Friedman Bone Rongeur
Catalog number
T731
Device description
T731 Micro-Friedman Bone Rongeur
Published
2024-07-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
EMHForceps, Rongeur, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMHForceps, Rongeur, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813677023223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813677023223008136770232238136770232230813677023223

GMDN Terms#

Term, Definition table
TermDefinition
Dental rongeurA strongly constructed dental instrument that is used in the removal of the sharp edges of the alveolar crest of the bone following tooth extraction. It has a forceps or pliers-like design terminating at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws that bite (cut) through the bone tissue. It is made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization;Dry Heat Sterilization

Regulatory Flags#

DUNS number
125850144
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813677025319PDT, Inc.T804 Beebee Crown Curved Scissors (10.5cm)T8052025-09-03
00813677025258PDT, Inc.AU026 Gracey 11/12AU0262025-08-14
00813677025265PDT, Inc.AU028 Gracey 13-14AU0282025-08-14
00813677025272PDT, Inc.AU061 Barnhart 5-6AU0612025-08-14
00813677025289PDT, Inc.AU110 H6-7AU1102025-08-14
00813677025296PDT, Inc.AU135 204SAU1352025-08-14
00813677025302PDT, Inc.AU138 Ouback JackAU1382025-08-14
00813677023018PDT, Inc.T315 Millimeter RulerT3152025-05-12
00813677025241PDT, Inc.R218 Montana Precision ProbeR2182025-05-07
00813677025234PDT, Inc.R245-M Mirror Handle (Cone-Socket)-Missions R245-M2025-04-23
00813677025210PDT, Inc.R908 - PDT Demo Wallet 3 Pack - HygieneR9082025-03-25
00813677025227PDT, Inc.R909 - PDT Wallet 3 Pack - DoctorR9092025-03-25
00813677025197PDT, Inc.R138-25 25th Anniversary Montana Jack®R138-252025-02-20
00813677025180PDT, Inc.R960 2024 Advent CalendarR9602024-11-27
00813677025173PDT, Inc.R960 2024 Advent CalendarR9602024-11-06
00813677024138PDT, Inc.T018FM Silicone Finger MatT018FM2024-10-16
00813677025159PDT, Inc.R338 21B-27 BurnisherR3382024-09-11
00813677025166PDT, Inc.R528 CSS-7 Composite SystemR5282024-09-11
00813677025142PDT, Inc.R985 Rev B Andy RDH Student KitsR983 Rev C2024-08-29
00813677025135PDT, Inc.R983 Rev C Basic Extraction KitR983 Rev C2024-08-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810158219229PRINCETONPrinceton Medical Group, Inc.EMH2026-03-12
00810158219076PRINCETONPrinceton Medical Group, Inc.EMH2026-03-11
00810158219083PRINCETONPrinceton Medical Group, Inc.EMH2026-03-11
00810158219120PRINCETONPrinceton Medical Group, Inc.EMH2026-03-11
04059453090195Hermann Medizintechnik GmbHHermann Medizintechnik GmbHEMH2026-01-29
D9281009301850RONGEUR DOUBLE ACTION RUSKIN CURVED 18CM, 5MMW.H. Holden, Inc.EMH2026-01-06
D9281009302390RONGEUR DOUBLE ACTION RUSKIN CURVED 23CM, 6MMW.H. Holden, Inc.EMH2026-01-06
B7688441020Buxton BioMedicalBuxton Biomedical IncEMH2025-12-31
B7688457751630Buxton BioMedicalBuxton Biomedical IncEMH2025-12-31
B76885362280Buxton BioMedicalBuxton Biomedical IncEMH2025-12-31
B76885362360Buxton BioMedicalBuxton Biomedical IncEMH2025-12-31
08809596474019Kerrison Rotating Rongeur ShaftHankil Tech Medical Co., Ltd.EMH2025-12-16
08809596474071Endo Scope Kerrision Rotating Rongeur ShaftHankil Tech Medical Co., Ltd.EMH2025-12-16
08809596474095Endo Scope Kerrision Rotating Rongeur ShaftHankil Tech Medical Co., Ltd.EMH2025-12-16
08809596474996Kerrison Rotating Rongeur HandleHankil Tech Medical Co., Ltd.EMH2025-12-16
B356ED107160American MedicalsAmerican MedicalsEMH2025-12-03
B76884332520Buxton BioMedicalBuxton Biomedical IncEMH2025-11-13
B76885300040Buxton BioMedicalBuxton Biomedical IncEMH2025-11-13
00198506084522ELMED INCORPORATEDELMED INCORPORATEDEMH2025-08-11
00198506084539ELMED INCORPORATEDELMED INCORPORATEDEMH2025-08-11
00198506084546ELMED INCORPORATEDELMED INCORPORATEDEMH2025-08-11
00198506084560ELMED INCORPORATEDELMED INCORPORATEDEMH2025-08-11
00198506084577ELMED INCORPORATEDELMED INCORPORATEDEMH2025-08-11
00198506084584ELMED INCORPORATEDELMED INCORPORATEDEMH2025-08-11
00198506084591ELMED INCORPORATEDELMED INCORPORATEDEMH2025-08-11
00198506084607ELMED INCORPORATEDELMED INCORPORATEDEMH2025-08-11
B76884850320Buxton BioMedicalBuxton Biomedical IncEMH2025-07-30
B76884850420Buxton BioMedicalBuxton Biomedical IncEMH2025-07-30
B76884850520Buxton BioMedicalBuxton Biomedical IncEMH2025-07-30
B76884852320Buxton BioMedicalBuxton Biomedical IncEMH2025-07-30