FDA.reportPublic FDA data

PDT, Inc.

Primary DI
00813677024589
Brand
PDT, Inc.
Company
PDT, INC.
Model
R438 Molt 2-4 Surgical Curette
Catalog number
R438
Device description
R438 Molt 2-4 Surgical Curette
Published
2024-06-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EMKCurette, Surgical, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMKCurette, Surgical, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813677024589PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813677024589008136770245898136770245890813677024589

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose curetteA hand-held manual surgical instrument designed for scraping and/or excising tissue from a wide variety of anatomical sites, and includes at least one non-dermal application (i.e., non-dedicated). It is typically made of high-grade stainless steel, available in a variety of shapes and sizes, and has an appropriately-shaped distal end (e.g., cup-, ring-, spoon-like). This is a single-use device.

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Dry Heat Sterilization""]"
Moist Heat or Steam Sterilization;Dry Heat Sterilization

Regulatory Flags#

DUNS number
125850144
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813677025395PDT, Inc.R117 Boge Precision DuoR1172026-05-12
00813677025388PDT, Inc.R098MB R098MB2026-04-27
00813677023230PDT, Inc.T732 Stieglitz 30° Splinter ForcepT7322024-07-02
00813677025364PDT, Inc.T055-3 Double-Sided PrecisionReflect HD Mirror ThrT055-32025-10-20
00813677025371PDT, Inc.T055-6 Double-Sided PrecisionReflect HD Mirror TweT055-62025-10-20
00813677025326PDT, Inc."T050-3 #5 PrecisionReflect HD Mirror (15/16"") ThT050-32025-10-16
00813677025333PDT, Inc."T050-12 #5 PrecisionReflect HD Mirror (15/16"") TT050-122025-10-16
00813677025340PDT, Inc."T051-3 #4 PrecisionReflect HD Mirror (7/8"") ThreT051-32025-10-16
00813677025357PDT, Inc."T051-12 #4 PrecisionReflect HD Mirror (7/8"") ThrT051-122025-10-16
00813677025319PDT, Inc.T805 Beebee Crown Curved Scissors (10.5cm)T8052025-09-03
00813677025258PDT, Inc.AU026 Gracey 11/12AU0262025-08-14
00813677025265PDT, Inc.AU028 Gracey 13-14AU0282025-08-14
00813677025272PDT, Inc.AU061 Barnhart 5-6AU0612025-08-14
00813677025289PDT, Inc.AU110 H6-7AU1102025-08-14
00813677025296PDT, Inc.AU135 204SAU1352025-08-14
00813677025302PDT, Inc.AU138 Ouback JackAU1382025-08-14
00813677022455PDT, Inc.T044 Titanium TweezersT0442024-07-05
00813677023612PDT, Inc.T845 Bone Carrier (3.5mm)T8452024-07-02
00813677023629PDT, Inc.T846 Bone Carrier (4.5mm)T8462024-07-02
00813677023636PDT, Inc.T847 Bone Carrier (6mm)T8472024-07-02

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Primary DI, Brand, Company table
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G149TBSB7930TBS BASICSACME ENTERPRISE.EMK2026-05-21
G149TBSB7940TBS BASICSACME ENTERPRISE.EMK2026-05-21
G149TBSB7950TBS BASICSACME ENTERPRISE.EMK2026-05-21
G149NP380620NPSACME ENTERPRISE.EMK2026-05-01
G149NPSCL0NPSACME ENTERPRISE.EMK2026-05-01
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10889950126414Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMK2026-04-06
10889950126421Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMK2026-04-06
00348783007770Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMK2026-04-02
00348783007787Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMK2026-04-02
00348783007794Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMK2026-04-02
00348783007800Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMK2026-04-02
00348783007817Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMK2026-04-02
00348783007824Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMK2026-04-02
00348783007848Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMK2026-04-02
00192896122444Gracey CuretteSONTEC INSTRUMENTS, INC.EMK2025-10-28
00192896119758Gracey CuretteSONTEC INSTRUMENTS, INC.EMK2024-09-05
00813677025135PDT, Inc.PDT, INC.EMK2024-08-12
B382SD9348330830Surgical DirectSurgical Direct, Inc.EMK2024-07-11
00813677024497PDT, Inc.PDT, INC.EMK2024-06-27