FDA.reportPublic FDA data

Hu-Friedy

Primary DI
10889950128241
Brand
Hu-Friedy
Company
HU-FRIEDY MFG. CO., LLC
Model
SH5/33V9E2
Catalog number
SH5/33V9E2
Device description
#H5/33 DE Scaler, EE2 #9 Hdl, Purple
Published
2020-12-30
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
EJBHANDLE, INSTRUMENT, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJBHandle, Instrument, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889950128241PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088995012824110889950128241

GMDN Terms#

Term, Definition table
TermDefinition
Dental mirror, reusableA hand-held, dental instrument intended to be used by a dentist for intraoral inspection or inspection and retraction. It typically consists of a stainless steel shaft terminating at the distal end in a small round mirror that is angled to the shaft. 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
G149TBSB71050TBS BASICSACME ENTERPRISE.EJB2026-05-22
G149TBSB71060TBS BASICSACME ENTERPRISE.EJB2026-05-22
G149TBSB71070TBS BASICSACME ENTERPRISE.EJB2026-05-22
G149TBSB71080TBS BASICSACME ENTERPRISE.EJB2026-05-22
00348783010206Premier Mirror HandlesPREMIER DENTAL PRODUCTS COMPANYEJB2026-03-17
G1493807306TBS DentalACME ENTERPRISE.EJB2026-03-02
00841013120459Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EJB2026-01-06
00841013120466Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EJB2026-01-06
30371347019668Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
30371347019675Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
30371347019682Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
30371347019699Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
00371347017724Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
00371347017748Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
00883205032164Slide PackerULTRADENT PRODUCTS, INC.EJB2025-08-21
00883205032157Slide PackerULTRADENT PRODUCTS, INC.EJB2025-08-19
08806343925183ever KITShinhung MST Co., Ltd.EJB2025-07-28
08806343925213TAPER KITShinhung MST Co., Ltd.EJB2025-07-28
08806343925220GUIDE KITShinhung MST Co., Ltd.EJB2025-07-28
08057639710567Specialist OrganizerMC BIO SRLEJB2025-06-23
08057639710574Tip with Indexable StopMC BIO SRLEJB2025-06-23
08057639710598Offset Tip SPMC BIO SRLEJB2025-06-23
08057639710604Long Tip SPMC BIO SRLEJB2025-06-23
08057639710628GBR MODULAR SETMC BIO SRLEJB2025-06-23
08057639712066Handle - Straight MDFMC BIO SRLEJB2025-06-23
08057639712073Handle - Straight - ErgalMC BIO SRLEJB2025-06-23
08057639712080Handle - Straight SP (TiN)MC BIO SRLEJB2025-06-23
08057639712097Handle - Asym. - ErgalMC BIO SRLEJB2025-06-23
08057639712103Handle - Asym. - SP (TiN)MC BIO SRLEJB2025-06-23
08057639712110Handle - Asym. - TitaniumMC BIO SRLEJB2025-06-23