FDA.reportPublic FDA data

Hu-Friedy MFG Co., LLC.

Primary DI
10889950097196
Brand
Hu-Friedy MFG Co., LLC.
Company
HU-FRIEDY MFG. CO., LLC
Model
SMF2/378
Device description
#2/3 MacFarlane DE Scaler, #7, Blue
Published
2023-04-07
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMQHOE, PERIODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMQHoe, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889950097196PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088995009719610889950097196

GMDN Terms#

Term, Definition table
TermDefinition
Manual dental scaler, reusableA hand-held dental instrument designed for removing calculus and other accretions from the surface and between the teeth during dental cleaning and periodontal (gum) therapy. It is typically designed as a one-piece instrument with a pointed, distal end of various shapes and sizes. Also known as a periodontic scaler, it can be a single-ended or double-ended instrument with a handle at the proximal end or positioned centrally. It is usually made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10889950157326Hu-FriedyIMNO24511C2026-05-26
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840018661318Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMQ2026-01-28
D928400512RD0CHISEL 7-10 D/E ROUND HANDLEW.H. Holden, Inc.EMQ2026-01-06
10889950133603Hu-FriedyHU-FRIEDY MFG. CO., LLCEMQ2025-12-19
00841336108738Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMQ2025-11-11
00841013116513American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EMQ2024-11-06
00841013116537American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EMQ2024-11-06
10889950023102Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-06-27
10889950025526Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-06-27
10889950092887Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-06-27
10889950093693Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-06-27
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10889950023294Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950025489Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950025496Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950025588Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950025595Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950030636Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950030643Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950030650Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950030667Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950033194Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950033200Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950033361Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950033378Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950089863Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950091897Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950092764Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950092849Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950092979Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950096922Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07