FDA.report

PDT, Inc.

Primary DI
00813677023124
Brand
PDT, Inc.
Company
PDT, INC.
Model
T356 Amalgam Well
Catalog number
T356
Device description
T356 Amalgam Well
Published
2024-06-27
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
EKICarrier, Amalgam, Operative

Product Code Classifications

CodeDeviceSpecialtyClass
EKICarrier, Amalgam, OperativeDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00813677023124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00813677023124008136770231248136770231240813677023124

GMDN Terms

TermDefinition
Dental amalgam wellA small cup where mixed amalgam is put before being taken up by an amalgam carrier or an amalgam syringe. This is a reusable device.

Sterilization Methods

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

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00813677023070PDT, Inc.PDT, INC.EKI2024-07-01
00840105223160ZOLL DENTALZoll-DentalEKI2024-05-31
00840105223177ZOLL DENTALZoll-DentalEKI2024-05-31
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00840105223191ZOLL DENTALZoll-DentalEKI2024-05-31
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