FDA.reportPublic FDA data

Integra® Jarit®

Primary DI
M2743854401
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
385-440
Catalog number
385440
Device description
Sheehy Ossicle Holding Clamp, 4-3/4", 1.5mm x 4mm, 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
OTC
false
Sterile
false
Single use
false

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
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
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
10381780190165Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYF2018-04-03
10381780458333Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYF2018-03-02
M2743854301Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYF2018-03-02