FDA.report

PDT, Inc.

Primary DI
00813677021182
Brand
PDT, Inc.
Company
PDT, INC.
Model
R194 Probe 11 (3-6-8-11)
Catalog number
R194
Published
2021-04-30
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

Contact Domains

Product Codes

CodeName
EIXProbe, Periodontic

Product Code Classifications

CodeDeviceSpecialtyClass
EIXProbe, PeriodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00813677021182PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00813677021182008136770211828136770211820813677021182

GMDN Terms

TermDefinition
Periodontal probe, reusableA hand-held dental instrument intended to be inserted into a periodontal pocket around a tooth to measure the depth of the periodontal pocket, in order to assess the health of the periodontium and to monitor the progress of disease. It is typically made of high-grade stainless steel and has a distal end with a thin, angled or curved blunt tip with scaled markings to indicate measurements (typically millimetres). This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
800-240-9895customer.care@pdtdental.com

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
false
Serial number
false
Manufacturing date on label
false
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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