FDA.reportPublic FDA data

Integra® Jarit®

Primary DI
M2742751351
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
275-135
Catalog number
275135
Device description
Bunnell Hand Drill, 5-1/2", Jacobs Chuck, Aluminum
Published
2018-01-31
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
HBDHANDPIECE (BRACE), DRILL

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780185314PrimaryGS10
M2742751351SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178018531410381780185314

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
DM exempt
false
Premarket exempt
true
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
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
10381780189459Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBD2018-04-02
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
M2742951111Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBD2018-01-31
M2742951171Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBD2018-01-31