FDA.report

Integra® Jarit®

Primary DI
M274X314111
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
X31411
Catalog number
X31411
Device description
Halle Ethmoid Curette 8-1/2", Oval Cup, Malleable Shaft
Published
2018-05-03
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

Related Records

Contact Domains

Product Codes

CodeName
KAPCURETTE, NASAL

Product Code Classifications

CodeDeviceSpecialtyClass
KAPCurette, NasalEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10381780406990PrimaryGS10
M274X314111SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1038178040699010381780406990

GMDN Terms

TermDefinition
Ethmoid curetteA slender, hand-held, manual surgical instrument designed for excision of the ethmoid cells (spaces in the ethmoid sinuses) or a portion of the ethmoid bone (i.e., ethmoidectomy). The instrument typically has two ring-shaped ends that are usually sharp on both sides; it is typically made of high-grade stainless steel. This is a reusable device.

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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