FDA.report

Integra® Jarit®

Primary DI
M2743852951
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
385-295
Catalog number
385295
Device description
Shea Fenestra Hook, 6-1/4", 0.6mm Tip, Angled 45°
Published
2018-03-22
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

Related Records

Contact Domains

Product Codes

CodeName
JYLHOOK, MICROSURGICAL EAR

Product Code Classifications

CodeDeviceSpecialtyClass
JYLHook, Microsurgical EarEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10381780198543PrimaryGS10
M2743852951SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1038178019854310381780198543

GMDN Terms

TermDefinition
Incus hookA shaft-like, hand-held manual surgical instrument intended to be used during ear/nose/throat (ENT) surgery for fixation or traction of the incus bone (the anvil bone of the group of three that form the sound-transmitting ossicles in the middle ear). The device tapers towards the distal end to form a hook or multiple hooks used in the procedure. The proximal end forms a handle which may vary in shape. In multiple hook designs, the hooks are in parallel. This is a reusable device.

Device Sizes

TypeValueUnit
Angle45degree
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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

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