FDA.reportPublic FDA data

HU-FRIEDY

Primary DI
10889950044237
Brand
HU-FRIEDY
Company
HU-FRIEDY MFG. CO., LLC
Model
CPOU35
Catalog number
CPOU35
Device description
DE Carver, OU 35 (13-10-16)
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
EJZKNIFE, MARGIN FINISHING, OPERATIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJZKnife, Margin Finishing, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889950044237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088995004423710889950044237

GMDN Terms#

Term, Definition table
TermDefinition
Dental restoration carver, amalgam, reusableA hand-held manual dental instrument intended to be used for producing and perfecting anatomical forms in dental amalgam restorations, typically by cutting, scraping, paring, and smoothing finishes and modelling patterns intraorally. It will typically be a double-ended instrument with working ends of various shapes and designs, and a central handle. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
true

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
08800075604484OSUNG MNDOSUNG MND Co., Ltd.EJZ2024-02-26
08800075604460OSUNG MNDOSUNG MND Co., Ltd.EJZ2024-02-19
08800075604477OSUNG MNDOSUNG MND Co., Ltd.EJZ2024-02-19
08800075604491OSUNG MNDOSUNG MND Co., Ltd.EJZ2024-02-19
10889950110512Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEJZ2023-07-19
10889950110529Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEJZ2023-07-19
10889950121204Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEJZ2023-06-27
10889950043360Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEJZ2023-04-07
10889950043377Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEJZ2023-04-07
10889950080662Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEJZ2023-04-07
10889950080679Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEJZ2023-04-07
D943G18010GargPower Dental U.S.A. Inc.EJZ2023-02-28
D943G18120GargPower Dental U.S.A. Inc.EJZ2023-02-28
10889950139353Hu-FriedyHU-FRIEDY MFG. CO., LLCEJZ2022-10-17
10889950139360Hu-FriedyHU-FRIEDY MFG. CO., LLCEJZ2022-10-17
10889950139414Hu-FriedyHU-FRIEDY MFG. CO., LLCEJZ2022-10-17
10889950139421Hu-FriedyHU-FRIEDY MFG. CO., LLCEJZ2022-10-17
10889950139438Hu-FriedyHU-FRIEDY MFG. CO., LLCEJZ2022-10-17
10889950139513Hu-FriedyHU-FRIEDY MFG. CO., LLCEJZ2022-10-17
10889950044251HU-FRIEDYHU-FRIEDY MFG. CO., LLCEJZ2022-01-20
10889950133153Hu-FriedyHU-FRIEDY MFG. CO., LLCEJZ2021-10-08
D9431816D0Power Dental USAPower Dental U.S.A. Inc.EJZ2021-07-13
D9431812M00Power Dental USAPower Dental U.S.A. Inc.EJZ2021-07-13
D9431816D00Power Dental USAPower Dental U.S.A. Inc.EJZ2021-07-13
D9431812L00Power Dental USAPower Dental U.S.A. Inc.EJZ2021-07-13
D943N1812L00Power Dental U.S.A., Inc.Power Dental U.S.A. Inc.EJZ2021-07-13
D943N1812M00Power Dental U.S.A., Inc.Power Dental U.S.A. Inc.EJZ2021-07-13
D943N1816D00Power Dental U.S.A., Inc.Power Dental U.S.A. Inc.EJZ2021-07-13
D94318020Power Dental USAPower Dental U.S.A. Inc.EJZ2021-06-20
D94318130Power Dental USAPower Dental U.S.A. Inc.EJZ2021-06-20