FDA.report

PDT, Inc.

Primary DI
00813677022882
Brand
PDT, Inc.
Company
PDT, INC.
Model
T234 Aspirating Anesthetic Syringe Small
Catalog number
T234
Device description
T234 Aspirating Anesthetic Syringe Small
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

Related Records

Product Codes

CodeName
EICSyringe, Periodontic, Endodontic, Irrigating
EJISyringe, Cartridge

Product Code Classifications

CodeDeviceSpecialtyClass
EICSyringe, Periodontic, Endodontic, IrrigatingDental1
EJISyringe, CartridgeDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00813677022882PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00813677022882008136770228828136770228820813677022882

GMDN Terms

TermDefinition
Dental irrigation/aspiration syringeA hand-held manual dental device (a plunger-type syringe) designed to inject and/or aspirate a volume of solution into the working area in the oral cavity. It typically consists of a small syringe (e.g., 3 ml) and is used for washing and aspirating the pulp cavity and root canal to remove debris. It is hand-operated by the user who exerts a steady pressure on, e.g., thumb rings and/or swivel finger bars, which exerts pressure on the syringe plunger forcing the washing/rinsing fluids through an attached needle (e.g., a blunt or very fine needle) directly at the operative site. 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
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

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