FDA.report

PDT, Inc.

Primary DI
00813677024497
Brand
PDT, Inc.
Company
PDT, INC.
Model
R983 Basic Extraction Kit
Catalog number
R983
Device description
Kit Includes: T015E-U FlipTop™ Cassette 'E' – Utility T018FM Silicone Finger Mat 10.75”x 8” R245 Mirror Handle (Cone-Socket) R437 Lucas 86 T040 Tweezers COLLEGE T050 #5 Front Surface Mirror, Cone-Socket, (15/16') T080 Tissue pliers ADSON T100 Retractor Caewood Minnesota 16 T102 Root elevator Seldin No. 301 straight T104 Root elevator Seldin 34S T118 Periosteal Elevator Molt 9 Hollow handle T235 Aspirating Anesthetic Syringe Medium T320 Elevator Fragment Ejector/Root Tip Pick, HEIDBRINK T704 Scalpel handle T714 TC Needle Holder CRILE WOOD T813 Scissors Goldman-Fox curved 12.5 T850 Miller-Colburn Bone File #1, Serrated
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
EJYPliers, Operative

Product Code Classifications

CodeDeviceSpecialtyClass
EJYPliers, OperativeDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00813677024497PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00813677024497008136770244978136770244970813677024497

GMDN Terms

TermDefinition
Bone file/rasp, manual, reusableA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. 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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