FDA.report

PDT, Inc.

Primary DI
00813677024879
Brand
PDT, Inc.
Company
PDT, INC.
Model
R919 PDT Exam Kit
Catalog number
R919
Device description
Kit Includes: T005A-F A-Series FlipTop™ Cassette - Fixed Rack 5 R166 Explorer 5 R195 Probe 12 (3-6-9-12) R245 Cone Socket Mirror Handle T042 Meriam Tweezers T050 #5 Mirror (15/16")
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
EIXProbe, Periodontic

Product Code Classifications

CodeDeviceSpecialtyClass
EIXProbe, PeriodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00813677024879PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00813677024879008136770248798136770248790813677024879

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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