FDA.reportPublic FDA data

Integra® Ruggles®-Redmond™

Primary DI
M274RN62301
Brand
Integra® Ruggles®-Redmond™
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
RN6230
Catalog number
RN6230
Device description
Rhoton-Type Microsurgery Dissection Expanded Set, 19 Instruments and Tray
Published
2018-03-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
OJGNeurological tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJGNeurological TrayNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780232070PrimaryGS10
M274RN62301SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178023207010381780232070

GMDN Terms#

Term, Definition table
TermDefinition
Neurosurgical procedure kit, non-medicated, reusableA collection of various neurosurgical instruments, dressings and the necessary materials used to perform a neurosurgical procedure. It does not contain pharmaceuticals. 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
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
10197106896327CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956489165CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956491625CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956492141CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956502581CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956518384CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956526235CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956526501CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956527553CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956528185CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956528437CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956528727CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10809160526897HalyardAVID MEDICAL, INC.OJG2026-07-08
10198956416079CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-06
10198956502062CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-06
10198956515536CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-06
10198956524873CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-06
10198956525344CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-06
10198956527348CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-06
10809160526187HalyardAVID MEDICAL, INC.OJG2026-06-25
10809160526194HalyardAVID MEDICAL, INC.OJG2026-06-25
10809160525999HalyardAVID MEDICAL, INC.OJG2026-06-24
10809160526040HalyardAVID MEDICAL, INC.OJG2026-06-24
10198956340169CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-23
10198956365674CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-23
10198956491120CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-23
10198956502796CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-23
10198956512085CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-23
10198956512825CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-23
10198956513808CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-23