FDA.reportPublic FDA data

Integra® Jarit®

Primary DI
M2746301111
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
630-111
Catalog number
630111
Device description
Strong Forceps, 9-1/2" working length, Roto-Lok™, Monopolar, double action, insulated, 3.5mm
Published
2016-08-24
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
KNFCOAGULATOR-CUTTER, ENDOSCOPIC, UNIPOLAR (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNFCoagulator-Cutter, Endoscopic, Unipolar (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K932456000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K932456000JARIT SURGICAL INSTRUMENTSJ. Jamner Surgical Instruments, Inc.1994-04-21KNF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780152002PrimaryGS10
M2746301111SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178015200210381780152002

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, monopolar, reusableAn electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe with controls) and requires a patient contact return electrode to complete the circuit. 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
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
05708265016280LiNA Gold Loop™LiNA Medical AGKNF2026-04-02
05708265016327LiNA Gold Loop™LiNA Medical AGKNF2026-04-02
05708265016365LiNA Gold Loop™LiNA Medical AGKNF2026-04-02
10817929020364Sonata® Dispersive ElectrodeGynesonics, Inc.KNF2021-07-07
30817929020177Sonata® RFA Handpiece Cable, ReusableGynesonics, Inc.KNF2021-07-07
14042761086254OlympusOLYMPUS Winter & Ibe GmbHKNF2020-07-31
14042761086278OlympusOLYMPUS Winter & Ibe GmbHKNF2020-07-31
00810116021666Dornier MedTechDORNIER MEDTECH AMERICA, INC.KNF2020-06-19
00810116021673Dornier MedTechDORNIER MEDTECH AMERICA, INC.KNF2020-06-19
00810116021680Dornier MedTechDORNIER MEDTECH AMERICA, INC.KNF2020-06-19
00810116021642Dornier MedTechDORNIER MEDTECH AMERICA, INC.KNF2020-06-18
00810116021659Dornier MedTechDORNIER MEDTECH AMERICA, INC.KNF2020-06-18
10817929020241Sonata® Intrauterine Ultrasound ProbeGynesonics, Inc.KNF2019-05-10
10817929020142Sonata® IUUS Probe Soaking CylinderGynesonics, Inc.KNF2019-05-10
10817929020180Sonata® System Cart Gynesonics, Inc.KNF2019-05-10
10817929020197Sonata® SMART TabletGynesonics, Inc.KNF2019-05-10
10817929020203Sonata® System Radiofrequency GeneratorGynesonics, Inc.KNF2019-05-10
10817929020326Sonata® Sonography-Guided Transcervical Fibroid Ablation System Gynesonics, Inc.KNF2019-05-10
30817929020092Sonata® Intrauterine Ultrasound ProbeGynesonics, Inc.KNF2019-05-10
10381780490128Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKNF2019-03-06
10381780490135Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKNF2018-09-14
04048551102503n.a.Karl Storz GmbH & Co. KGKNF2018-07-21
04048551102527n.a.Karl Storz GmbH & Co. KGKNF2018-07-21
04048551094631BETTOCCHIKarl Storz GmbH & Co. KGKNF2017-10-20
04048551364864n.a.Karl Storz GmbH & Co. KGKNF2017-05-19
04048551347645n.a.Karl Storz GmbH & Co. KGKNF2016-12-22
10653405035060CONMEDConmed CorporationKNF2016-09-24
10653405035091CONMEDConmed CorporationKNF2016-09-24
00817428020721ModulapATC TECHNOLOGIES, INC.KNF2016-09-24
04046963682262AESCULAPAesculap AGKNF2016-09-24