FDA.report

PDT, Inc.

Primary DI
00813677024503
Brand
PDT, Inc.
Company
PDT, INC.
Model
R984 Composite & Crown Prep Kit
Catalog number
R984
Device description
Kit Contains: (T0E15-F) E-Series FlipTop™ Cassette - Fixed Rack 15 with Standard Divider (R166) Explorer 5 (R245) Mirror Handle (Cone-Socket) (R283) IPC- Non Coated (R286) G2 Thin Composite (R287) G3 Thin Composite (R363S) 113 Straight Serrated Cord Packer (R375) Mixing Spatula/Applicator (R386) 38-39 Excavator (T040) Tweezers COLLEGE (T046) Articulating Paper Forceps MILLER (T050) #5 Mirror (15/16") (T235) Aspirating Anesthetic Syringe Medium (T319) Bur Block (T800) IRIS Scissors, curved
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
EKCExcavator, Dental, Operative

Product Code Classifications

CodeDeviceSpecialtyClass
EKCExcavator, Dental, OperativeDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00813677024503PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00813677024503008136770245038136770245030813677024503

GMDN Terms

TermDefinition
Suture scissorsA hand-held surgical instrument used during surgery to cut suture or ligature material, i.e., to divide lengths or remove excessive/unwanted ends. It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically metallic and is available in various designs and sizes; the blades may have different shapes, e.g., they can be curved or straight with a hook-like tip to capture the suture/ligature as it is cut. It is not a dedicated ophthalmic device. 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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