FDA.report

HU-FRIEDY

Primary DI
10889950085605
Brand
HU-FRIEDY
Company
HU-FRIEDY MFG. CO., LLC
Model
PLG1665
Catalog number
PLG1665
Device description
PLG3HES AMAL.PLUGGER DE U.MRLD
Published
2020-11-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EKGCONDENSER, AMALGAM AND FOIL, OPERATIVE

Product Code Classifications

CodeDeviceSpecialtyClass
EKGCondenser, Amalgam And Foil, OperativeDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10889950085605PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088995008560510889950085605

GMDN Terms

TermDefinition
Endodontic pluggerA hand-held, manually-operated, dental instrument specifically designed to compress filling materials in a root canal, mainly in an axial direction. The working distal end is cylindrical or tapered, circular in cross-section, and has a flat-tipped end. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)483-7433info@hu-friedy.com

Regulatory Flags

DUNS number
005085972
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10889950156008Hu-FriedyIM53FMC22026-03-05
10889950156015Hu-FriedyIM56FMC22026-03-05
10889950155445Hu-FriedyIM4160C4AF2026-02-26
10889950155452Hu-FriedyIM4162C4AF2026-02-26
10889950155469Hu-FriedyIM4163C4AF2026-02-26
10889950155476Hu-FriedyIM4165C4AF2026-02-26
10889950155483Hu-FriedyIM4166C4AF2026-02-26
10889950155490Hu-FriedyIM4168C4AF2026-02-26
10889950155506Hu-FriedyIM4169C4AF2026-02-26
10889950154714Hu-FriedyIM8125E1L2026-02-18
10889950154721Hu-FriedyIM8126E1L2026-02-18
10889950154738Hu-FriedyIM8128E1L2026-02-18
10889950154745Hu-FriedyIM8129E1L2026-02-18
10889950154752Hu-FriedyIM4225LP32026-02-18
10889950154769Hu-FriedyIM4226LP32026-02-18
10889950154776Hu-FriedyIM4228LP32026-02-18
10889950154783Hu-FriedyIM4229LP32026-02-18
10889950154790Hu-FriedyIM4220LP32026-02-18
00889950143285PWR Classic PowderAP-CN2024-09-06
00889950143346PWR Classic PowderAP-CM2024-09-06

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00840018672307Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-02-11
00840018670365Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-02-10
00840018671867Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-02-10
00840018671904Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-02-10
00840018666092Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-02-09
00840018662506Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-01-29
00840018663275Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-01-29
00840018661325Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-01-28
00840018661387Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-01-28
00840018661769Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-01-28
00840018661936Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-01-28
05010058178106InstrapacROBINSON HEALTHCARE LIMITEDEKG2025-06-23
00889813065976Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKG2024-12-12
00889813065952Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKG2024-11-30
00889813065969Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKG2024-11-30
00889813065983Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKG2024-11-30
00889813065990Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKG2024-11-30
00889813066003Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKG2024-11-30
00889813066027Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKG2024-11-30
00889813066034Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKG2024-11-30
00889813066010Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKG2024-10-01
00842517118553Karl SchumacherKarl Schumacher Dental, LLCEKG2024-05-06
00842517118560Karl SchumacherKarl Schumacher Dental, LLCEKG2024-05-06
00842517118577Karl SchumacherKarl Schumacher Dental, LLCEKG2024-05-06
00842517118584Karl SchumacherKarl Schumacher Dental, LLCEKG2024-05-06
00842517118591Karl SchumacherKarl Schumacher Dental, LLCEKG2024-05-06
08800075604668OSUNG MNDOSUNG MND Co., Ltd.EKG2024-03-04
08800075604675OSUNG MNDOSUNG MND Co., Ltd.EKG2024-03-04
08800075609670OSUNG MNDOSUNG MND Co., Ltd.EKG2024-03-04
08800075609717OSUNG MNDOSUNG MND Co., Ltd.EKG2024-03-04