FDA.reportPublic FDA data

Hu-Friedy MFG Co., LLC.

Primary DI
10889950018092
Brand
Hu-Friedy MFG Co., LLC.
Company
HU-FRIEDY MFG. CO., LLC
Model
PCV11PT
Device description
#11 COLORVUE Probe Pts, 3-6-8-11, 12
Published
2023-07-19
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIXPROBE, PERIODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIXProbe, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889950018092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088995001809210889950018092

GMDN Terms#

Term, Definition table
TermDefinition
Dental surgical probe, reusableA slender, rod-like, hand-held manual dental surgical instrument intended to be used to explore, measure and/or perform therapeutic procedures during various types of dental surgical intervention. The distal end may be needle-like, hooked, or blunt; it is made of flexible or rigid metallic and/or synthetic polymer material and it may have scaled markings for measurements. 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
true
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
G149NPPEXP0NPSACME ENTERPRISE.EIX2026-05-01
00348783006438Premier ProbesPREMIER DENTAL PRODUCTS COMPANYEIX2026-03-17
00348783006629Premier ProbesPREMIER DENTAL PRODUCTS COMPANYEIX2026-03-17
00348783006766Premier ProbesPREMIER DENTAL PRODUCTS COMPANYEIX2026-03-17
00348783006780Premier ProbesPREMIER DENTAL PRODUCTS COMPANYEIX2026-03-17
00348783006803Premier ProbesPREMIER DENTAL PRODUCTS COMPANYEIX2026-03-17
00348783006810Premier ProbesPREMIER DENTAL PRODUCTS COMPANYEIX2026-03-17
00348783006827Premier ProbesPREMIER DENTAL PRODUCTS COMPANYEIX2026-03-17
00348783006841Premier ProbesPREMIER DENTAL PRODUCTS COMPANYEIX2026-03-17
00840018674516Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIX2026-03-12
B382SD502210Surgical DirectSurgical Direct, Inc.EIX2026-02-26
00840018674097Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIX2026-02-11
00840018667051Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIX2026-02-10
00840018667143Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIX2026-02-10
00840018667792Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIX2026-02-10
00840018666498Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIX2026-02-09
00840018666597Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIX2026-02-09
B382SD12240Surgical DirectSurgical Direct, Inc.EIX2026-02-04
B382SD923898000Surgical DirectSurgical Direct, Inc.EIX2026-02-04
00840018662582Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIX2026-01-29
00840018663268Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIX2026-01-29
00840018661646Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIX2026-01-28
00841013120473Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EIX2026-01-06
D9284002151M0PERIO PROBE MARQUIS STYLE #1 CC 3-6-9-12W.H. Holden, Inc.EIX2026-01-06
00841336100985Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIX2025-11-11
B382SD9252232010Surgical DirectSurgical Direct, Inc.EIX2025-09-18
B382SD49400Surgical DirectSurgical Direct, Inc.EIX2025-08-07
B382SD936091010Surgical DirectSurgical Direct, Inc.EIX2025-08-07
B382SD93770610810Surgical DirectSurgical Direct, Inc.EIX2025-08-07
B382SD9377061100Surgical DirectSurgical Direct, Inc.EIX2025-08-07