FDA.reportPublic FDA data

Integra® Jarit®

Primary DI
10381780189459
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
295116
Catalog number
295-116
Device description
Integra® Jarit® Hudson Cerebellar Extension
Published
2018-04-02
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
HBDHANDPIECE (BRACE), DRILL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBDHandpiece (Brace), DrillNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780189459PrimaryGS10
M2742951161SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178018945910381780189459

GMDN Terms#

Term, Definition table
TermDefinition
Manual cranial rotary handpiece, reusableA manually-powered, hand-held, surgical device intended to be used to remove circular sections of the skull vault (calvarium) to provide access to the interior for diagnosis (e.g., the insertion of a neuroscope), or treatments [e.g., to alleviate intracranial pressure (ICP)], or for the removal of a bone flap for brain surgery. It is typically a drill brace or a housing containing bevelled and/or straight teethed gears rotated via a side handle, and a Jacobs chuck or gripping collet to attach an exchangeable rotating endpiece (e.g., a cranial drill, bur, trephine or perforator). 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
10381780191070Integra® Jarit®400293400-2932018-04-02
10381780193180Integra® Jarit®P408P4082018-04-02
10381780197997Integra® Jarit®380232380-2322017-09-29
10381780198000Integra® Jarit®380233380-2332018-03-22
10381780198543Integra® Jarit®385295385-2952018-03-22
10381780220121Integra® Jarit®P666P6662018-01-31
10381780390381Integra® Jarit®380230380-2302018-02-16
10381780390398Integra® Jarit®380231380-2312018-02-16
10381780456469Integra® Jarit®405225405-2252018-01-31
10381780457190Integra® Jarit®P667P6672018-01-31
10381780458159Integra® Jarit®385315385-3152018-03-01
10381780458166Integra® Jarit®385316385-3162018-03-01
10381780487708Integra® Miltex®MH21-300MH21-3002018-08-22
10381780503910Integra® Miltex®PM-666PM-6662020-10-01
10381780520665CereLink™82684582-68452020-04-01
10381780087984Integra®375001237500122018-10-26
10381780081371Integra®372201137220112018-10-24
10381780081388Integra®372201237220122018-10-24
10381780081906Integra®372206937220692018-10-24
10381780081913Integra®372207037220702018-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887482125229Symmetry BunnellASPEN SURGICAL PRODUCTS, INC.HBD2024-08-12
G586N6871060Novo SurgicalNOVO SURGICAL, INC.HBD2023-12-18
G586N6872220Novo SurgicalNOVO SURGICAL, INC.HBD2023-12-18
G586N8761800Novo SurgicalNOVO SURGICAL, INC.HBD2023-12-18
G586N8761810Novo SurgicalNOVO SURGICAL, INC.HBD2023-12-18
G586N8761820Novo SurgicalNOVO SURGICAL, INC.HBD2023-12-18
G586N8761880Novo SurgicalNOVO SURGICAL, INC.HBD2023-12-18
00190776375553MillenniumAvalign Technologies, Inc.HBD2023-09-08
00842331168611Novo Surgical Inc. NOVO SURGICAL, INC.HBD2022-11-13
00842331130731Novo Surgical Inc. NOVO SURGICAL, INC.HBD2022-11-10
00842331136108Novo Surgical Inc. NOVO SURGICAL, INC.HBD2022-11-10
04038653068821MACRO-LINEAesculap AGHBD2020-08-24
04038653069460AESCULAPAesculap AGHBD2020-05-08
04038653162956AESCULAPAesculap AGHBD2020-04-22
10381780494997Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBD2018-10-24
10381780495000Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBD2018-10-24
10381780495017Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBD2018-10-24
H83426240Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBD2018-10-24
H83426320Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBD2018-10-24
H83426350Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBD2018-10-24
M2742951161Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBD2018-04-02
10381780185314Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBD2018-01-31
10381780190097Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBD2018-01-31
10381780190158Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBD2018-01-31
M2742751351Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBD2018-01-31
M2742951111Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBD2018-01-31
M2742951171Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBD2018-01-31