FDA.reportPublic FDA data

Integra® Jarit®

Primary DI
10381780190165
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
385440
Catalog number
385-440
Device description
Sheehy Ossicle Holding Clamp, Vertical Groove
Published
2018-04-03
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
JYFCLAMP, OSSICLE HOLDING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYFClamp, Ossicle HoldingEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780190165PrimaryGS10
M2743854401SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178019016510381780190165

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, alligator, reusableA long, thin, hand-held manual surgical instrument designed to facilitate grasping and manipulation of soft-tissues/anatomical structures [typically during ear/nose/throat (ENT) surgery]; it is not intended for insertion through an endoscope, nor into the eye, and is not a dedicated biopsy device. Commonly referred to as alligator- or crocodile-forceps, it has a slender body (to allow for restricted access) and small grasping blades which are hinged close to the distal (working) end. It is a metallic device available in various sizes/lengths; some types may include an integrated suction channel. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Device Identifier

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
00757770417766Bausch + LombBausch & Lomb IncorporatedJYF2025-08-08
00840183524562BR Surgical, LLCBR Surgical, LLCJYF2024-05-28
G586E7216220Novo SurgicalNOVO SURGICAL, INC.JYF2023-12-18
G586E7216230Novo SurgicalNOVO SURGICAL, INC.JYF2023-12-18
00190776318925MillenniumAvalign Technologies, Inc.JYF2023-06-23
14026704805621PILLINGTELEFLEX INCORPORATEDJYF2022-12-08
54026704805629PILLINGTELEFLEX INCORPORATEDJYF2022-12-08
00887482043752Symmetry SheehyASPEN SURGICAL PRODUCTS, INC.JYF2022-09-28
00887482114407Symmetry DerlackiASPEN SURGICAL PRODUCTS, INC.JYF2022-09-28
00190660014919Ambler SurgicalAMBLER SURGICAL CORP.JYF2021-01-07
00190660017767Ambler SurgicalAMBLER SURGICAL CORP.JYF2021-01-07
M63334170280JEDMEDJEDMED INSTRUMENT COMPANYJYF2020-09-01
04046964588204AESCULAPAESCULAP, INC.JYF2020-05-08
04046964589386AESCULAPAESCULAP, INC.JYF2020-05-08
10381780081258Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYF2018-10-24
10381780081265Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYF2018-10-24
10381780074564Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYF2018-09-17
10885403012242V. MuellerSTERIS CORPORATIONJYF2018-08-02
M2743854401Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYF2018-04-03
10381780458333Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYF2018-03-02
M2743854301Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYF2018-03-02