FDA.reportPublic FDA data

Integra® Ruggles®-Redmond™

Primary DI
10381780401285
Brand
Integra® Ruggles®-Redmond™
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
R0323
Catalog number
R0323
Device description
"Integra® Ruggles®-Redmond™ PPSU Handle Cobb Elevator, 14-3/4"" Long, 1"" Wide"
Published
2018-05-02
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
HTEELEVATOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEGElevator, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1
HTEElevatorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780401285PrimaryGS10
M274R03231SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178040128510381780401285

GMDN Terms#

Term, Definition table
TermDefinition
Bone lever/elevator, reusableA manual surgical instrument designed to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. It is made of high-grade stainless steel and is available in a wide variety of sizes, designs, and blade shapes. It is typically a robust instrument with a blunted blade with no cutting edge at the distal end that can be pointed, rounded, flat, curved or hook shaped and a handle of various designs at the proximal end. Some types can have special functions, e.g., for angle joint operations or for luxation procedures. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
081277700
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
10381780024507Integra® Jarit®100539100-5392018-01-22
10381780024514Integra® Jarit®100540100-5402018-01-22
10381780031901Integra® Miltex®27-20227-2022015-09-22
10381780031918Integra® Miltex®27-20427-2042015-09-22
10381780031925Integra® Miltex®27-20627-2062015-09-22
10381780031932Integra® Miltex®27-20827-2082015-09-22
10381780031949Integra® Miltex®27-21027-2102015-09-22
10381780031956Integra® Miltex®27-21227-2122015-09-22
10381780063865Integra® Miltex®4-515C4-515C2018-02-15
10381780063872Integra® Miltex®4-5224-5222018-02-15
10381780063896Integra® Miltex®461146112018-02-15
10381780063902Integra® Miltex®461546152018-02-15
10381780064206Integra® Miltex®33-3833-382018-02-14
10381780128779Integra® Miltex®30-174030-17402016-08-03
10381780133810Integra® Jarit®320437320-4372016-08-12
10381780134503Integra® Jarit®6531016531012018-01-15
10381780136408Integra® Jarit®X37254X372542016-08-14
10381780142874Integra® Jarit®230250230-2502016-08-14
10381780143048Integra® Jarit®320195320-1952016-08-14
10381780143055Integra® Jarit®320196320-1962016-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G4251902480My MedicalMy Medical Store LLCGEG2026-05-04
09348811078988INKAThe Trustee for KAISER FAMILY TRUSTHTE2026-03-18
07898506841370QuinelatoSchobell Industrial LtdaHTE2023-01-10
07898506841356QuinelatoSchobell Industrial LtdaHTE2022-12-16
07898506841363QuinelatoSchobell Industrial LtdaHTE2022-12-16
10381780423997Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-08-16
10381780424116Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-08-16
10381780445517Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-08-16
10381780407706Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-05-03
10381780408468Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTE2018-05-03
10381780408475Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTE2018-05-03
10381780401254Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-05-02
10381780401254Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTE2018-05-02
10381780401261Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTE2018-05-02
10381780401261Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-05-02
10381780401278Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-05-02
10381780401278Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTE2018-05-02
10381780401292Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-05-02
10381780401292Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTE2018-05-02
10381780409779Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-05-02
10381780188865Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-04-02
10381780188865Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTE2018-04-02
10381780188872Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-04-02
10381780188872Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTE2018-04-02
10381780188889Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTE2018-04-02
10381780188889Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-04-02
10381780188896Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTE2018-04-02
10381780188896Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-04-02
10381780189282Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTE2018-04-02
10381780189282Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-04-02