FDA.report

PDT, Inc.

Primary DI
00813677024909
Brand
PDT, Inc.
Company
PDT, INC.
Model
R926 PDT Diamond Tissue Grafting Kit
Catalog number
R926
Device description
Kit Includes: (T015E-F) E-Series FlipTop™ Cassette - Fixed Rack 15 with Standard Divider (R077) Younger-Good 7-8 (R226) 23 Explorer-UNC15 Probe (R245) Cone Socket Mirror Handle (R442) Periosteal Elevator (2mm) (R443) Periosteal Elevator (3mm) (R444) End Cutting Intrasulcular Knife (R445) Modified Orban Knife (T050) #5 Mirror (15/16") (T085) Diamond Coated Corn Suture Pliers (T087) Diamond Coated Micro Straight Pliers (17.5cm) (T088) Castroviejo Straight Tungsten Carbide Needle Holder (17.5cm) (T705) Adjustable Scalpel Handle (T815) Goldman-Fox Curved Black Scissors (12.5cm)
Published
2024-06-26
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

Related Records

Product Codes

CodeName
HXKHolder, Needle; Orthopedic

Product Code Classifications

CodeDeviceSpecialtyClass
HXKHolder, Needle; OrthopedicOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00813677024909PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00813677024909008136770249098136770249090813677024909

GMDN Terms

TermDefinition
Dental surgical probe, reusableA slender, rod-like, hand-held manual dental surgical instrument intended to be used to explore, measure and/or perform therapeutic procedures during various types of dental surgical intervention. The distal end may be needle-like, hooked, or blunt; it is made of flexible or rigid metallic and/or synthetic polymer material and it may have scaled markings for measurements. This is a reusable device.

Sterilization Methods

Method
Dry Heat Sterilization;Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
125850144
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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

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