FDA.reportPublic FDA data

Integra® Jarit®

Primary DI
M2744504221
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
450-422
Catalog number
450422
Device description
Tonsil Needle With Luer-Lock, 4-1/8", 0.7mm Diameter, Angled
Published
2018-04-09
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
KBRNEEDLE, TONSIL SUTURING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBRNeedle, Tonsil SuturingEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780467113PrimaryGS10
M2744504221SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178046711310381780467113

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Outer Diameter65Millimeter

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

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Primary DI, Brand, Company table
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00194613115449MSI Precision Specialty InstrumentsMed Saver, Inc.KBR2025-08-01
00194613109752MSI Precision Specialty InstrumentsMed Saver, Inc.KBR2025-03-21
00190776388744MillenniumAvalign Technologies, Inc.KBR2024-11-14
00887482173800Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KBR2024-08-15
00887482046562Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KBR2024-08-01
00887482119167Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KBR2024-08-01
00887482119174Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KBR2024-08-01
00887482123966Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KBR2024-08-01
00887482123973Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KBR2024-08-01
00840343722203GEN2SURGIX MEDICAL LLCKBR2024-04-23
G586E8306200Novo SurgicalNOVO SURGICAL, INC.KBR2023-12-18
00840343720414GEN2SURGIX MEDICAL LLCKBR2023-12-08
00190776303990MillenniumAvalign Technologies, Inc.KBR2023-11-16
00190776304904MillenniumAvalign Technologies, Inc.KBR2023-11-16
00190776044077AvalignAvalign Technologies, Inc.KBR2023-09-28
00190776290733MILLENNIUMAvalign Technologies, Inc.KBR2023-09-28
00190776319625MILLENNIUMAvalign Technologies, Inc.KBR2023-09-28
00190776319700MILLENNIUMAvalign Technologies, Inc.KBR2023-09-28
00190776319885MILLENNIUMAvalign Technologies, Inc.KBR2023-09-28
00190776322281MILLENNIUMAvalign Technologies, Inc.KBR2023-09-28
00190776322298MILLENNIUMAvalign Technologies, Inc.KBR2023-09-28
00190776373801MILLENNIUMAvalign Technologies, Inc.KBR2023-09-28
00190776378264MILLENNIUMAvalign Technologies, Inc.KBR2023-09-28
00840343716240GEN2SURGIX MEDICAL LLCKBR2023-03-22
00840343715427GEN2SURGIX MEDICAL LLCKBR2022-12-29
14026704804815PILLINGTELEFLEX INCORPORATEDKBR2022-12-08
14026704805010PILLINGTELEFLEX INCORPORATEDKBR2022-12-08