FDA.reportPublic FDA data

Integra® Jarit®

Primary DI
M27462523531
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
625-2353
Device description
DETACH BABY METZENBAUM SCISSORS INSERT
Published
2016-09-09
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
10381780151920PrimaryGS10
M27462523531SecondaryHIBCC0
00381780151923Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038178015192010381780151920
00381780151923003817801519233817801519230381780151923

GMDN Terms#

Term, Definition table
TermDefinition
Suture knot pusher, reusableA hand-held manual surgical instrument that enables the user performing an internal suturing procedure (e.g., suturing a heart valve in the thoracic cavity) to advance suture knots created extracorporeally to the point of appropriate suture tension. It is a long, thin, rod-like device that has a guiding mechanism (e.g., an eyelet or groove) at its distal end, allowing it to be steered down one end of the suture as it pushes the knot with its blunted nose. Saline may be used to lubricate the suture and the knot pusher if necessary. 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
3
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

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Primary DI, Brand, Company table
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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