FDA.reportPublic FDA data

Hu-Friedy MFG Co., LLC.

Primary DI
10889950024901
Brand
Hu-Friedy MFG Co., LLC.
Company
HU-FRIEDY MFG. CO., LLC
Model
SC13/14R8
Device description
13/14 Columbia Rigid Curette Resin8 HDL
Published
2023-03-30
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
EMSCURETTE, PERIODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMSCurette, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889950024901PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088995002490110889950024901

GMDN Terms#

Term, Definition table
TermDefinition
Periodontal curetteA hand-held dental instrument with a sharp, hollow-ground blade, usually rounded and semicircular in cross-section, used with a pulling action to remove calculus of periodontal pockets and smooth root surfaces; it is not a gingival retraction cord packing tool. It is typically a double-ended instrument with a handle positioned centrally and is made of metal. 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
00348783007466Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007473Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007534Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007541Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007558Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007565Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007572Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007596Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007602Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007619Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007671Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007756Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783008159Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783008166Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783008173Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783008197Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783008210Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783008227Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783008234Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783008241Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783008258Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
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