FDA.reportPublic FDA data

Integra® Jarit®

Primary DI
M274P54451
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
P5445
Catalog number
P5445
Device description
Carroll Retractor Hook, 5", 3mm, With Bead Stop
Published
2018-03-23
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
GADRETRACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780218692PrimaryGS10
M274P54451SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178021869210381780218692

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue surgical hook, reusableA hand-held, shaft-like, manual surgical instrument designed for hooking and applying traction to specific soft-tissues of interest (e.g., skin, vessel, organ, and/or duct) to allow surgical intervention on those tissues. It is not primarily designed for pulling aside tissues for surgical access purposes (i.e., not a retractor). The device includes a handle and tapers towards the distal end to form a slender hook/parallel hooks. 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
00198506091872ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-10
00810158211193PRINCETONPrinceton Medical Group, Inc.GAD2026-07-10
00810158219861PRINCETONPrinceton Medical Group, Inc.GAD2026-07-10
00888937033687ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033694ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033700ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033717ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033724ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033731ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033748ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033755ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033762ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033779ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033786ONETRAC™ LXSCoopersurgical, Inc.GAD2026-07-10
00888937033793ONETRAC™ LXSCoopersurgical, Inc.GAD2026-07-10
00888937033809ONETRAC™ LXSCoopersurgical, Inc.GAD2026-07-10
00888937033816ONETRAC™ LXSCoopersurgical, Inc.GAD2026-07-10
07640177823564Neo Medical RetractorsNeo Medical SAGAD2026-07-10
07640177823571Neo Medical RetractorsNeo Medical SAGAD2026-07-10
07640177823588Neo Medical RetractorsNeo Medical SAGAD2026-07-10
07640177823595Neo Medical RetractorsNeo Medical SAGAD2026-07-10
07640177823601Neo Medical RetractorsNeo Medical SAGAD2026-07-10
07640177823748Neo Medical RetractorsNeo Medical SAGAD2026-07-10
07640177823755Neo Medical RetractorsNeo Medical SAGAD2026-07-10
07640177823762Neo Medical RetractorsNeo Medical SAGAD2026-07-10
07640177823779Neo Medical RetractorsNeo Medical SAGAD2026-07-10
07640177823786Neo Medical RetractorsNeo Medical SAGAD2026-07-10
07640177823793Neo Medical RetractorsNeo Medical SAGAD2026-07-10
07640177823809Neo Medical RetractorsNeo Medical SAGAD2026-07-10
B382SD9044561000Surgical DirectSurgical Direct, Inc.GAD2026-07-10