FDA.report

Hu-Friedy

Primary DI
10889950139612
Brand
Hu-Friedy
Company
HU-FRIEDY MFG. CO., LLC
Model
AZIMENDOKIT
Catalog number
AZIMENDOKIT
Published
2022-10-05
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

Related Records

Contact Domains

Product Codes

CodeName
FSMTRAY, SURGICAL, INSTRUMENT

Product Code Classifications

CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10889950139612PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088995013961210889950139612

GMDN Terms

TermDefinition
Dental/maxillofacial surgical procedure kit, non-medicated, reusableA collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a reusable device.

Sterilization Methods

Method

Contacts

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
true
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 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 DIBrandCompanyProduct codePublished
00850075235063TESA IF Screw SystemTesa Medical, Inc.FSM2026-05-26
00850075235070TESA Tensioner SystemTesa Medical, Inc.FSM2026-05-26
00850075235179TESA Tensioner SystemTesa Medical, Inc.FSM2026-05-26
10889950157326Hu-FriedyHU-FRIEDY MFG. CO., LLCFSM2026-05-26
00888118150240PURE PECTUSKLS-Martin L.P.FSM2026-05-25
00888118150257PURE PECTUSKLS-Martin L.P.FSM2026-05-25
00888118150264PURE PECTUSKLS-Martin L.P.FSM2026-05-25
00888118150448IXOSKLS-Martin L.P.FSM2026-05-25
00888118150455IXOSKLS-Martin L.P.FSM2026-05-25
00888118150462IXOSKLS-Martin L.P.FSM2026-05-25
00888118150479IXOSKLS-Martin L.P.FSM2026-05-25
00888118150486IXOSKLS-Martin L.P.FSM2026-05-25
00888118150493IXOSKLS-Martin L.P.FSM2026-05-25
00888118153029L1 STERNALKLS-Martin L.P.FSM2026-05-25
00888118153050IXOSKLS-Martin L.P.FSM2026-05-25
00888118153067IXOSKLS-Martin L.P.FSM2026-05-25
00888118153074IXOSKLS-Martin L.P.FSM2026-05-25
00888118153081IXOSKLS-Martin L.P.FSM2026-05-25
00888118154613LEVEL ONEKLS-Martin L.P.FSM2026-05-25
07898663491562HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663493108HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663493467HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663495263HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663495270HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663495751HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663496239HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663497267HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663498080HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663498097HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663499292HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24