FDA.reportPublic FDA data

Depuy Synthes

Primary DI
00190776028176
Brand
Depuy Synthes
Company
Avalign Technologies, Inc.
Model
03.520.009
Device description
Double Ended Periosteal Elevator, Angle, 19 cm
Published
2017-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEGElevator, Surgical, General & Plastic Surgery
KADElevator, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEGElevator, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1
KADElevator, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776028176PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776028176001907760281761907760281760190776028176

GMDN Terms#

Term, Definition table
TermDefinition
Dental root elevatorA hand-held manual dental instrument intended to be used as a lever during the extraction of a tooth or retained roots. It is typically a one-piece instrument with a strong but slender blade at the distal working end, or it may be double-ended with a central handle. It is available in a variety of sizes and blade designs and is pushed in between the gums and the tooth exterior to loosen the tissue surrounding the tooth. Sometimes this can be enough to loosen and extract the tooth without the use of other instruments. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(877)289-1096product.questions@avalign.com

Regulatory Flags#

DUNS number
792528510
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190776408534Millennium72-9819S2025-08-19
00190776406769MillenniumM1571842025-07-24
00190776392789Millennium72-9820PA2025-05-05
00190776384715Millennium72-402229IL2024-08-22
00190776383084Millennium72-9820PP2024-07-24
00190776300524Millennium72-5298200102023-11-15
00190776300531Millennium72-61948002023-11-15
00190776301576Millennium72-4262822023-11-15
00190776301750Millennium72-9820OLY2023-11-15
00190776374846Millennium72-98842023-09-08
00190776375515MillenniumM1570572023-09-08
00190776378592MillenniumM133562023-09-08
00190776294830Millennium72-5062642022-12-12
00190776189396Millennium72-58192021-11-02
00190776189501MillenniumFTIMG105802021-11-02
00190776205485Millennium72-3612061B2021-11-02
00190776157296MillenniumMFOCAAF375GA2021-01-22
00190776421311Millennium72-4286052026-05-05
00190776421328Millennium1-3552062026-05-05
00190776421335Millennium1-S50177512026-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846338005467FreerELLIQUENCE, LLCGEG2026-06-01
G383S1061WM8535437SURJEXSURJEXGEG2026-05-31
G4251902480My MedicalMy Medical Store LLCGEG2026-05-04
09348811101655INKAThe Trustee for KAISER FAMILY TRUSTKAD2026-04-24
09348811102522INKAThe Trustee for KAISER FAMILY TRUSTKAD2026-04-24
09348811101433INKAThe Trustee for KAISER FAMILY TRUSTKAD2026-03-18
10381780423997Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-08-16
10381780424116Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-08-16
10381780402718Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAD2018-05-03
10381780402725Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAD2018-05-03
10381780402947Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAD2018-05-03
10381780407706Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-05-03
10381780407744Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAD2018-05-03
10381780407751Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAD2018-05-03
10381780407768Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAD2018-05-03
10381780401254Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-05-02
10381780401261Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-05-02
10381780401278Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-05-02
10381780401285Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-05-02
10381780401292Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-05-02
10381780409779Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-05-02
10381780190035Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAD2018-04-03
10381780190042Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAD2018-04-03
10381780192695Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAD2018-04-03
10381780188865Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-04-02
10381780188872Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-04-02
10381780188889Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-04-02
10381780188896Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-04-02
10381780189282Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-04-02
10381780189299Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-04-02