FDA.reportPublic FDA data

Integra® Jarit®

Primary DI
M2742601161
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
260-116
Device description
MICHELE TREPHINE
Published
2016-08-14
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
HBGDRILLS, BURRS, TREPHINES & ACCESSORIES (MANUAL)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBGDrills, Burrs, Trephines & Accessories (Manual)Neurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780158691PrimaryGS10
M2742601161SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178015869110381780158691

GMDN Terms#

Term, Definition table
TermDefinition
Bone trephineAn orthopaedic surgical blade designed to cut and remove circular sections of bone, typically for biopsy or percutaneous bone graft harvesting. It is typically a hollow cylinder with a circular, saw-like serrated working edge. It is an exchangeable device that may be attached to a manually-operated handle or to a powered rotary surgical handpiece. The device is typically made of high-grade stainless steel. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length6Inch
Outer Diameter5Millimeter

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
false
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
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
10381780127901Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-17
10381780127918Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-17
10381780127925Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-17
10381780127956Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-14
10381780127963Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-14
10381780128182Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-14
10381780128199Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-14
10381780128205Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-14
10381780136408Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-14
10381780142928Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-14
10381780126744Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780126751Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780126768Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780126775Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780126782Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780126836Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780126874Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780126904Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780126911Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780127048Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780127055Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780127062Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780127079Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780127086Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780127093Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780127109Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780127116Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780127123Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780127130Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780127147Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11