FDA.report

Integra® Jarit®

Primary DI
M2743802321
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
380-232
Device description
Allport Incus Hook, 6-3/4", Angled 90°, 3mm Tip
Published
2017-09-29
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
GDGHOOK, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications

CodeDeviceSpecialtyClass
GDGHook, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10381780197997PrimaryGS10
M2743802321SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1038178019799710381780197997

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
Device Size Text, specify0
Length3Millimeter

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
00190776417901MillenniumAvalign Technologies, Inc.GDG2026-03-23
00190776418335MillenniumAvalign Technologies, Inc.GDG2026-03-23
00190776418366MillenniumAvalign Technologies, Inc.GDG2026-03-23
04052536215522tezoUlrich GmbH & Co. KGGDG2026-03-16
00810158219328PRINCETONPrinceton Medical Group, Inc.GDG2026-03-12
00190776417826MillenniumAvalign Technologies, Inc.GDG2026-03-11
00190776417673MillenniumAvalign Technologies, Inc.GDG2026-03-04
00190776417512MillenniumAvalign Technologies, Inc.GDG2026-02-27
00190776416775MillenniumAvalign Technologies, Inc.GDG2026-02-20
00190776415761MillenniumAvalign Technologies, Inc.GDG2026-02-04
00190776415204MillenniumAvalign Technologies, Inc.GDG2026-01-27
00198506087431ELMED INCORPORATEDELMED INCORPORATEDGDG2026-01-07
03662663277082Timberline Lateral Fusion SystemHighridge Medical, LLCGDG2025-12-18
03662663277099Timberline Lateral Fusion SystemHighridge Medical, LLCGDG2025-12-18
03662663192798Breckenridge ACDF SystemHighridge Medical, LLCGDG2025-12-15
03662663192804Breckenridge ACDF SystemHighridge Medical, LLCGDG2025-12-15
00190776415129MillenniumAvalign Technologies, Inc.GDG2025-12-03
03662663131230Disc Preparation InstrumentsHighridge Medical, LLCGDG2025-12-03
03662663131247Disc Preparation InstrumentsHighridge Medical, LLCGDG2025-12-03
09348811019653INKAThe Trustee for KAISER FAMILY TRUSTGDG2025-12-02
09348811108647INKAThe Trustee for KAISER FAMILY TRUSTGDG2025-11-28
09348811155368INKAThe Trustee for KAISER FAMILY TRUSTGDG2025-11-28
00810207782605Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGDG2025-11-24
00810207782612Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGDG2025-11-24
00810207782629Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGDG2025-11-24
00810207782636Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGDG2025-11-24
00810207782643Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGDG2025-11-24
00810207782650Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGDG2025-11-24
00810207782667Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGDG2025-11-24
00810207782674Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGDG2025-11-24