FDA.report

PDT, Inc.

Primary DI
00813677023322
Brand
PDT, Inc.
Company
PDT, INC.
Model
T785 Rubberdam clamp forceps IVORY
Catalog number
T785
Device description
T785 Rubberdam clamp forceps IVORY
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
EJGForceps, Rubber Dam Clamp

Product Code Classifications

CodeDeviceSpecialtyClass
EJGForceps, Rubber Dam ClampDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00813677023322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00813677023322008136770233228136770233220813677023322

GMDN Terms

TermDefinition
Rubber dam clamp forcepsA hand-held dental instrument used for the insertion and removal of rubber dam clamps. It is typically designed with permanently joined handles pivoted scissor-like, and has small projections at the working end that fit into corresponding holes in the rubber dam clamp. It will typically have a sliding lock mechanism that locks the handles in position while the operator moves the rubber dam clamp around the tooth. 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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