FDA.report

Integra® Jarit®

Primary DI
M2744301031
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
430-103
Catalog number
430103
Device description
La Force Adenotome, 8-3/4", 16mm Cut, Size 2, Medium
Published
2018-03-02
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
KBHADENOTOME

Product Code Classifications

CodeDeviceSpecialtyClass
KBHAdenotomeEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10381780199854PrimaryGS10
M2744301031SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1038178019985410381780199854

GMDN Terms

TermDefinition
AdenotomeA hand-held manual surgical instrument designed to excise hypertrophic lymphoid tissue in the nasopharynx (i.e., pharyngeal tonsils or adenoids) during a procedure known as an adenoidectomy. It is typically a long, slender instrument with cutting blades at the working end, and a handle with a mechanism to operate the blades. It is available in various designs and sizes and may be a one-piece instrument or require the insertion of the blades into the handle. 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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