FDA.report

PDT, Inc.

Primary DI
00813677024893
Brand
PDT, Inc.
Company
PDT, INC.
Model
R925 PDT Bone Grafting Kit
Catalog number
R925
Device description
Kit Includes: (T009D-F) D-Series FlipTop™ Cassette - Fixed Rack 9 (R245) Cone Socket Mirror Handle (R432) Slade Blade™ 1 (R433) Slade Blade™ 2 (R434) Slade Blade™ 3 (R435) Slade Blade™ 4 (R436) Slade Blade™ 5 (T050) #5 Mirror (15/16") (T704) Scalpel Handle (T710) Castroviejo Straight Tungsten Carbide Needle Holder (14cm) (T740) Prichard Periosteal Elevator
Published
2024-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HXKHolder, Needle; Orthopedic

Product Code Classifications

CodeDeviceSpecialtyClass
HXKHolder, Needle; OrthopedicOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00813677024893PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00813677024893008136770248938136770248930813677024893

GMDN Terms

TermDefinition
Dental mirror, reusableA hand-held, dental instrument intended to be used by a dentist for intraoral inspection or inspection and retraction. It typically consists of a stainless steel shaft terminating at the distal end in a small round mirror that is angled to the shaft. 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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