FDA.reportPublic FDA data

Integra® Jarit®

Primary DI
10381780192787
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
P0695
Catalog number
P0695
Device description
"Integra® Jarit® Little Imbrication Needle, 5"""
Published
2018-09-12
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
GDLNEEDLE, SUTURING, REUSABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDLNeedle, Suturing, ReusableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780192787PrimaryGS10
M274P06951SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178019278710381780192787

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle, reusableA non-sterile, cylindrical-shaped, solid, metal instrument intended to be used to insert and pull suture material through tissue (e.g., skin, fascia, serous, vascular, or other tissue/organ) during surgical stitching of tissues. It is available in various lengths, curvatures, diameters, cross-sectional shapes, and distal end forms; included is the Reverdin type needle with an eye that can be opened and closed with a sliding mechanism on a handle intended to facilitate ease of suturing. This is a reusable device intended to be sterilized prior to use.

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
00190776428044MillenniumAvalign Technologies, Inc.GDL2026-08-27
04054462906604evonosevonos GmbH & Co. KGGDL2026-08-21
04054462906611evonosevonos GmbH & Co. KGGDL2026-08-21
04054462906628evonosevonos GmbH & Co. KGGDL2026-08-21
04054462906635evonosevonos GmbH & Co. KGGDL2026-08-21
04054462906642evonosevonos GmbH & Co. KGGDL2026-08-21
04054462906666evonosevonos GmbH & Co. KGGDL2026-08-21
04054462906918evonosevonos GmbH & Co. KGGDL2026-08-21
04054462906659evonosevonos GmbH & Co. KGGDL2026-08-18
04054462906673evonosevonos GmbH & Co. KGGDL2026-08-18
00194613031718MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613040130MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613054878MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613084950MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613112493MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613112509MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613112622MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613112684MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613113308MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613119843MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613119850MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613119874MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613119881MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613119898MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613119911MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613121129MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613121136MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00190776401764MillenniumAvalign Technologies, Inc.GDL2025-06-13
00190776397715MillenniumAvalign Technologies, Inc.GDL2025-05-16
00194613106218MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-03-21