FDA.report

Integra® Jarit®

Primary DI
M2743802701
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
380-270
Catalog number
380270
Device description
Andrew Mastoid Chisel, 5-7/8", 5mm Wide, Straight
Published
2018-01-31
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
JYDCHISEL, MASTOID

Product Code Classifications

CodeDeviceSpecialtyClass
JYDChisel, MastoidGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10381780198079PrimaryGS10
M2743802701SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1038178019807910381780198079

GMDN Terms

TermDefinition
Mastoid chiselA single-bladed, surgical instrument, bevelled on one side with a flat cutting edge that is used to cut and shape the mastoid process (the large projection of the temporal bone of the skull found immediately behind each ear) during ear/nose/throat (ENT) surgery. It is hand-held by the surgeon who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. It is typically a one-piece instrument 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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10381780544319Codman® CereLink®826820P826820P2025-03-12
10381780524106CODMAN® BACTISEAL®NS0344NS03442024-11-20
10381780525370CODMAN® BACTISEAL®NS5091NS50912024-11-20
10381780521280CODMAN® CERTAS® Plus828807PL82-8807PL2024-11-20
10381780535805CODMAN® CERTAS® Plus828813PL82-8813PL2024-11-20
10381780535843CODMAN® CERTAS® Plus828823PL82-8823PL2024-11-20
10381780535867CODMAN® CERTAS® Plus828827PL82-8827PL2024-11-20
10381780536970CODMAN® BACTISEAL®82174582-17452024-11-20
10381780536987CODMAN® BACTISEAL®82307282-30722024-11-20
10381780536994CODMAN® BACTISEAL®82307382-30732024-11-20
10381780537007CODMAN® BACTISEAL®82307482-30742024-11-20
10381780537014CODMAN® BACTISEAL®82174982-17492024-11-20
10381780537021CODMAN® BACTISEAL®82175082-17502024-11-20
10381780537038CODMAN® BACTISEAL®82308782-30872024-11-20
10381780537045CODMAN® BACTISEAL®82308882-30882024-11-20
10381780537052CODMAN® BACTISEAL®NS0338NS03382024-11-20
10381780537069CODMAN® BACTISEAL®NS0339NS03392024-11-20
10381780537076CODMAN® BACTISEAL®NS0340NS03402024-11-20
10381780537083CODMAN® BACTISEAL®NS0343NS03432024-11-20
10381780537090CODMAN® HAKIM® BACTISEAL®NS5048NS50482024-11-20

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04048266149190PediatrOS™ FlexTack™/ RigidTack™Merete GmbHJYD2021-11-01
00190660008499Ambler SurgicalAMBLER SURGICAL CORP.JYD2021-01-04
00190660008505Ambler SurgicalAMBLER SURGICAL CORP.JYD2021-01-04
00190660008512Ambler SurgicalAMBLER SURGICAL CORP.JYD2021-01-04
00190660008529Ambler SurgicalAMBLER SURGICAL CORP.JYD2021-01-04
00190660008536Ambler SurgicalAMBLER SURGICAL CORP.JYD2021-01-04
00190660008543Ambler SurgicalAMBLER SURGICAL CORP.JYD2021-01-04
00190660008604Ambler SurgicalAMBLER SURGICAL CORP.JYD2021-01-04
00190660008611Ambler SurgicalAMBLER SURGICAL CORP.JYD2021-01-04
00190660008628Ambler SurgicalAMBLER SURGICAL CORP.JYD2021-01-04
00190660008635Ambler SurgicalAMBLER SURGICAL CORP.JYD2021-01-04
00190660008642Ambler SurgicalAMBLER SURGICAL CORP.JYD2021-01-04
00190660008659Ambler SurgicalAMBLER SURGICAL CORP.JYD2021-01-04
M2743802711Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYD2018-09-12
M2743802721Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYD2018-09-12
M2743802731Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYD2018-09-12
M274X208611Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYD2018-05-03
M274X208631Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYD2018-05-03
M274X208651Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYD2018-05-03
M274X208671Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYD2018-05-03
M274X208691Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYD2018-05-03
M274X208711Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYD2018-05-03
H834197500Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYD2017-12-21
H834197520Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYD2017-12-21
H834197540Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYD2017-12-21
H834197560Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYD2017-12-21
H834197580Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYD2017-12-21
H834197600Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYD2017-12-21